Recall — Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

September 17, 2007 — /FDA News/ — B. Braun Medical Inc., Bethlehem, PA, announced on July 30, 2007 a voluntary nationwide recall of Normal Saline Flush syringes with lot numbers ending in “SFR” due to an increase in customer complaints for particulate matter in the saline. The FDA has been apprised of this action.

The introduction of particulate matter into the blood stream may result in phlebitis and/or damage to vital organs such as the brain, kidneys, heart, and lungs. To a less likely extent, there is a potential for the development of pulmonary embolism or silicone embolism syndrome, which could cause severe injury and/or death. Symptoms would generally be expected to develop quickly and are unlikely to develop more than 24-48 hours after the administration of the product. However, the risk associated with use of this product is cumulative and increases with each additional exposure. A patient may not develop any
symptoms until they have received multiple doses of the product. To date, B. Braun has received no reports of any patient injury associated with this issue.

Customers that have the recalled product in their possession should discontinue use immediately and contact their physician if they have experienced any problems that may be related to usage of this product. Customers that have the affected product in their possession may contact the B. Braun Medical Inc. Customer Support Department at (800) 227-2862, Monday through Friday, 8 AM to 7 PM EST for instructions for handling the affected product and to arrange for replacement product.

This voluntary recall affects normal saline 3mL in 12mL syringes, designated by product code 513584, and normal saline 10mL in 12mL syringes, designated by product code 513587. Between June 11 and July 18 of this year, B. Braun Medical Inc. distributed approximately 33,000 units of product code 513584 and 1.2 million units of product code 513587 of lot numbers ending in “SFR” to hospitals and distributors. The product code, identified as REF, and lot number, identified as LOT, can be found on the syringe label just below the product description.

These flush syringes have been found to contain particulate matter, which has been identified as a medical grade silicone. While this silicone is biocompatible, routinely used in the medical device industry and is an expected component of these syringes, the visible particulate matter caused by the silicone in these “SFR” lots may pose a health risk.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Web site: www.fda.gov

September 12, 2007 — /PRNewswire/ — SOUTHAMPTON, PA — Environmental Tectonics Corporation’s Sterilization Systems Group (SSG) announced today the award of several new contracts spanning all markets and offerings. ETC has received new contracts for a pharmaceutical terminal sterilizer, a “sectional” animal cage and rack autoclave, an ethylene oxide sterilizer control system upgrade, and several new professional services Contracts. The service contracts include cycle development services, process engineering, and facility design and construction consulting. All three engineering services projects are from separate clients.

William F. Mitchell, president and chairman of ETC, states, “We are very pleased to have been selected for these new contracts [which] span all of our product offerings within the Sterilization Systems Group, even those in our newly formed Professional Service Group. Our Sterilization Systems Group is uniquely positioned within our respective industries to delivery highly customized solutions to the industries most demanding requirements. No other competitor offers the array of products and services that match ETC’s SSG.”

ETC’s Sterilization Systems Group offers steam and ethylene oxide sterilizers, services, consulting, and software systems to the medical device, pharmaceutical, biotechnology, and health-care industries. ETC’s SSG offers unique, customized solutions to unique process systems challenges.

ETC designs, develops, installs, and maintains aircrew training systems, public entertainment systems, process simulation systems (sterilization and environmental), clinical hyperbaric systems, environmental testing and simulation systems, and related products for domestic and international customers.

Source: Environmental Tectonics Corporation

Contact:
Duane D. Deaner, CFO
Tel: 215-355-9100 (ext. 1203)
Web site: www.etcusa.com

September 12, 2007 — AGAWAM, MA — A free white paper detailing sterility testing essentials for pharmaceutical manufacturers is now available for free download at http://www.microtestlabs.com/sterilitypaper/pharma-paper.htm.

In the white paper, titled “Pharmaceutical Sterility Testing: Essential Things You Must Know,” author Steven Richter, PhD, president and scientific founder of Microtest, presents the general concepts and problems associated with pharmaceutical sterility testing and reviews different testing methodologies.

Sterility testing of pharmaceutical articles is an essential element of the sterilization validation process as well as for routine release testing. USP requirements employ sterility testing as an official test to determine suitability of a lot. Understanding sterility testing is beneficial in terms of designing a validation process. In addition, the need to provide adequate and reliable test data is an important quality assurance issue.

Microtest is a leading provider of pharmaceutical services and offers fill/finish contract manufacturing services integrated with stability and testing services that lower costs, improve quality, and compress time-to-revenue for pharmaceutical manufacturers. With 15 years of experience in medical device testing, Microtest is a single-source manufacturing solution.

For more information download the free white paper or contact Microtest on the web: www.microtestlabs.com or toll-free: 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, MA, the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption.

September 12, 2007 — MONDSEE, AUSTRIA — Christ Water Technology Group takes over 76 percent of the stock of the Zeta Group, located in Tobelbad, near Graz (Austria) and thus expands its activities in the pharmaceutical and life-science sector even further. Zeta is primarily active in the central European market, with locations in Austria, Germany, France, Switzerland, and the Czech Republic. The company is a leading supplier of production systems and process equipment for the biotechnology and pharmaceutical industry, employs 240 people, and achieved a turnover of about 40 million euros in 2006. With this takeover, Christ extends its range of turnkey solutions, amongst other things.

“We are now the only manufacturer who can supply the entire process chain, including a higher-level automation system, for the biopharmaceutical industry, and in particular the sector of liquid processes. Many years of experience in the construction of biotechnological plants and the wide range of special high-tech equipment also permit Christ to achieve a sustainable development in the booming biotechnology market”, says Christ CEO Karl Michael Millauer, PhD. The engineering expertise and product competence of Zeta, combined with the global service and sales network of Christ offer comprehensive synergies and new chances for further growth. In the medium term, Christ plans to become one of the world’s leading supplier of pharmaceutical process and media systems.

Zeta was founded in 1987 and is today an established supplier of process technology, with the sales emphasis on central Europe. The special strengths of the company lie in the area of technical competence at a high quality level and a wide product portfolio of mixing systems, bioreactors, agitation and mixing technology, filtration, freeze and thaw systems, biopharmaceutical engineering with customer-specific automation solutions, and the erection of sterile systems. But the takeover will not only supplement the Christ product portfolio: Zeta, which will continue to operate under this name, also possesses a large and highly qualified construction department, which will strengthen the service sector of Christ.

Since Christ is a worldwide active company, the takeover offers both companies opportunities in the international marketplace. “Christ offers Zeta many new opportunities for development, with particular emphasis on the marketing and service at an international level,” says Zeta’s managing director Hermann Grundnig. “In addition, we can ensure that the rapid growth of our group remains sustainable and thus guarantee a successful and stable future for our employees, partners and customers,” adds his partner in the company management, Gerhard Zehetner.

September 7, 2007 — ARLINGTON HEIGHTS, IL — Registration is now open for the Institute of Environmental Sciences and Technology (IEST) Fall Conference, November 11-14, 2007. Learn about the latest research in the controlled environments and cleanroom industries from leading industry experts in your field. The meeting will take place at the Hilton Garden Inn in Hoffman Estates (Northwest Suburban Chicago), IL.

Some of the newest opportunities this year are the “Airborne Contamination Control in Healthcare Facilities” tutorial; the meeting of Working Group 205, Nanotechnology Safety: Applying Prevention through Design Principles to Nanotechnology Facilities; and a two-day “Access the Experts” onsite course on Vibration Basics A-Z.

The new tutorial, “Airborne Contamination Control in Healthcare Facilities,” will focus on health-care associated infection (HAI) and what factors are contributing to it and how technology developed for ultra-clean manufacturing facilities can be utilized to help reduce HAI. Joseph McGill of McGill Cleanroom Technology will instruct the course.

Other tutorials that will be offered, including two certificate programs, are:

• Cleanroom Housekeeping — This course, a hands-on, interactive demonstration, will explain how to implement housekeeping procedures essential to a cleanroom contamination control program based on IEST-RP-CC018.
• ISO Series Certificate Program
  * Understanding the ISO Series — This course will discuss the ISO 14644 documents with emphasis on ISO 14644 Cleanrooms and associated controlled environments–Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1.
  * Testing to Determine the Classification of Air Cleanliness — This course will cover the requirements of ISO 14644 Cleanrooms and associated controlled environments–Part 1: Classification of air cleanliness.
  * Testing Cleanroom Performance — This course will explore the technical requirements of ISO 14644 Cleanrooms and associated controlled environments–Part 3: Test methods, including required and optional tests for characterizing the performance of cleanrooms, except particle counting.
• Sterilization Certificate Program
  * Microbiology I — This class will provide a basic background in microbiology, cleaning and disinfection, and sterilization. It will cover terms, definitions, and concepts of microbiology. Cleaning and disinfection of equipment and surfaces in cleanrooms and other production areas will also be addressed.
  * Sterilization I — This class will cover radiation and ethylene oxide, the most common sterilization methods used in the medical device industry. The goal is to provide a basic understanding of the testing requirements and methods, including bioburden and sterility testing, as well as validation requirements.

To register, go to http://www.iest.org/fallconference/fallconference.htm. For further information regarding the Fall Conference and IEST publications, contact IEST by e-mail at [email protected] or call (847) 981-0100. IEST members receive a member registration discount. To become a member, contact Mara Douvris at [email protected].

About IEST
Founded in 1953, IEST is an international not-for-profit technical society of engineers, scientists, and educators that serves its members and the industries they represent (simulating, testing, controlling, and teaching the environments of earth and space) through education and the development of recommended practices and standards.

IEST is an ANSI-accredited standards-developing organization; Secretariat of ISO/TC 209 Cleanrooms and associated controlled environments; Administrator of the ANSI-accredited US TAG to ISO/TC 209; Administrator of the ANSI-accredited US TAG to ISO/TC 142 Cleaning equipment for air and other gases; and a founding member of the ANSI-accredited US TAG to ISO/TC 229 Nanotechnologies.

September 6, 2007 — CLEVELAND, OH — U.S. demand for infection prevention products and services will advance 4 percent annually to $16.8 billion in 2011. Growth will reflect increasing government and private pressures on the medical community to alleviate the widespread problem of healthcare-acquired infections (HAIs). Each year, HAIs afflict 2.3 million hospital and ambulatory patients and directly or indirectly lead to 99,000 deaths. These and other trends are presented in “Infection Prevention Products & Services,” a new study from The Freedonia Group, Inc., a Cleveland-based industry research firm.

The need for improved infection prevention strategies also exists throughout the life science sector. Stricter FDA standards for product quality control and quality assurance are forcing pharmaceutical and medical device producers to upgrade and expand sterilization and disinfection systems. The increasing use of biotechnology-derived microorganisms in investigative and testing procedures is broadening the infection prevention requirements of life science research and medical diagnostic concerns.

Among all infection prevention supplies, products used in surgery will continue to post the largest share of revenues. The elevated risk of transmitting air- and blood-borne pathogens in the operating room, coupled with upward trends in the number of operative procedures, will increase demand for surgical drapes and gowns 3.6 percent annually to $3.9 billion in 2011. Expanding preferences for enhanced barrier, level 4 textiles (which provide the strongest protection against pathogens) will impact favorably on growth. Cost containment pressures and advances in less invasive surgical techniques will moderate a faster rise in demand.

Disinfectants consumed by health care and life science facilities will comprise a $2.8 billion market in 2011. Pressures on health care facilities to adopt stricter staff hygiene and facility cleaning and disinfection practices will bolster gains. Additionally, growth in surgical procedures will boost the market for scrubs, patient preparations, and instrument disinfectants. Health care and life science markets for sterilization supplies, equipment and services will post moderate growth as medical providers and producers adopt stricter protocols to ensure the safety of new and reprocessed products. Stepped-up efforts to prevent the transmission of pathogenic microorganisms to and from staff personnel will boost demand for medical and laboratory gloves, face masks, and other protective apparel, especially in the health care sector.

Infection Prevention Products & Services (published September 2007, 242 pages) is available for $4,400 from The Freedonia Group, Inc., 767 Beta Drive, Cleveland, OH 44143-2326. For further details, please contact Corinne Gangloff by phone 440-684-9600, fax 440-646-0484, or e-mail [email protected]. Information may also be obtained through www.freedoniagroup.com.

Recall — Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

August 31, 2007 — /FDA News/ — WOODBURY, NY –American Pie, LLC, Woodbury, NY, is voluntarily recalling 1,440 cases of its Marie Callender Turtle Pies with date codes 07 (from military time 11:45 up to and including 16:00) 143 because the product was inadvertently shipped prior to the company obtaining satisfactory microbial test results. No specific pathogens were found. The recall is being conducted as a precautionary measure. Consumption of this product may lead to gastrointestinal illness, nausea, or vomiting.

The product was shipped to the following locations:
– Kroger Supermarkets: Columbus, OH; Houston, TX; Roanoke, VA; Dallas, TX; Atlanta, GA; Memphis, TN; Shelbyville, TN; Louisville, KY.
– Giant Eagle Supermarkets: Akron, Canton, Lake, Cleveland, Columbus, Erie, Toledo, Johnston (all in Ohio); also New Castle, MD; Pittsburgh, PA; and Youngstown, WV.
– Hy-Vee Supermarkets: Iowa, Illinois, Kansas, Minnesota, Maryland, Nebraska, and South Dakota.

There was no direct foreign distribution.

The pies are packaged in 28 oz. boxes with UPC code 12781 10280.

The recall was initiated after it was discovered that the product had been distributed without company authorization.

No illnesses have been reported to date in connection with this situation. Consumers who have purchased Marie Callender Turtle Pies with the above date codes are urged to return them to the place of purchase. Consumers with questions may contact the company at 1-888-339-7437, x3987.

Web site: www.fda.gov

Recall — Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

August 31, 2007 — /FDA News/ — SALINAS, CA — Metz Fresh, LLC is voluntarily recalling bagged spinach as a result of a positive test for Salmonella found during routine company testing.

The spinach is distributed under the label Metz Fresh, in both retail and food service packages. These include 10 and 16 oz bags as well as 4-2.5 lb. and 4 lb. cartons. The only Metz Fresh product affected is spinach that bears the tracking codes 12208114, 12208214 and 12208314. It was distributed in the continental United States and Canada.

There have been no reports of illness or problems related to this spinach.

Salmonella is a common food borne pathogen that can cause severe illnesses, including fever, abdominal cramps, and diarrhea. While most individuals recover in three to five days without medical intervention, the infection can be life-threatening to young children, the elderly and those with compromised immune systems. Consumers with any of these symptoms should call their physician.

Consumers are advised to discard this product or return it to the place of purchase for a refund. Consumers with questions about the recall should contact 831-386-1018.

“Nothing is more important to Metz Fresh than the safety of our consumers, period,” says Andrew Cumming, president of Metz Fresh. “As soon as we learned of the presumptive positive test, we directed all customers to hold all boxes of the spinach affected as a precaution. Now, with this positive test confirmation, there is no question that we would recall and destroy all spinach bearing these three codes.”

The positive test came during independent lab testing Metz Fresh conducts on all of its products. Through its labeling and numbering system, Metz Fresh has already tracked, located and put “holds” on the vast majority of the cartons of spinach affected. That spinach will not be released into the marketplace.

While the positive test came from only one sample of many on three packing lines, Metz Fresh has, as a precaution, chosen to recall all of the spinach from the “field lot” packed that day on all three lines. Metz Fresh is keeping appropriate authorities updated on the status of the voluntary recall.

Web site: www.fda.gov

September 4, 2007 — WESTBROOK, ME — ARTEL announces that Death Valley National Park will be the site of Mission #3 of the Extreme Pipetting Expedition. At Death Valley, located in the desert spanning Nevada and California, ARTEL will test how dry and hot environmental conditions alter pipetted volumes. Dry heat was chosen as the scientific focus of Mission #3 because many laboratory technicians commonly encounter this condition in their work environments. For example, laboratories using analytical instruments, ovens, incubators, freezers, and other devices using high power or open flames are prone to heat and low humidity. Dry heat can also be contributed by heating and air-conditioning systems not equipped with humidifiers. To ensure pipetting accuracy and precision and strengthen data integrity, it is essential that laboratory scientists understand and compensate for this source of error.

ARTEL will release the results from Mission #3 at the Association for Molecular Pathology (AMP) 2007 Annual Meeting and Exhibits (booth #54), November 7-10, 2007, at the Hyatt Regency Century Plaza Hotel in Los Angeles, CA.

A 3.3 million-acre desert, Death Valley was selected as the site for Mission #3 because it is iconic for its hot and dry climate. Surrounded by mountains, the valley captures and retains extreme amounts of heat to create one of the hottest environments on earth, commonly exceeding 49 degrees Celsius (120 degrees Fahrenheit). Death Valley is also the driest locale in the United States, receiving fewer than two inches of rain annually.

The Extreme Pipetting Expedition is a multi-phase, year-long scientific study to illustrate the impact of laboratory environmental conditions on pipetting performance and data integrity. Previous missions explored how barometric pressure and how pipetting warm and cold liquids affect data integrity. More information can be found at www.artel-usa.com/extreme.

About ARTEL
ARTEL is the worldwide leader in liquid handling quality assurance. ARTEL manufactures the most accurate, precise and easy-to-use systems for ensuring data integrity in liquid volume measurement. ARTEL systems, based on proprietary Ratiometric Photometry, conform to ISO 8655-7 and provide NIST-traceable results. In addition, ARTEL provides liquid handling quality assurance support and consultation services including on-site pipetting technique training and certification for pipette users and laboratory managers, as well as Liquid Handler Performance Verification services for automated laboratories. Since 1982, ARTEL technology has been proven in daily use in thousands of laboratories including pharmaceutical, clinical, forensic, public health, and environmental. Leading institutions such as Amgen, ARUP, Bristol-Myers Squibb, Celgene, Centers for Disease Control, DuPont, Eli Lilly, FBI, Genentech, Genomic Health, Mayo Clinic, Memorial Sloan-Kettering Cancer Center, Merck, Pfizer, Procter & Gamble and U.S. FDA depend on ARTEL technology to help them meet their objectives for quality and productivity.

September 4, 2007 — /PRnewswire/ — MILAN, ITALY — Manz Automation AG (Reutlingen, Germany), a leading systems and components supplier, and Synova SA (Lausanne, Switzerland), the world pioneer of water jet-guided laser technology, today unveiled the ILE 2400, an inline laser edge isolation system for photovoltaic (PV) manufacturing of mono- and multi-crystalline solar cells.

Integrated with Synova’s proprietary water jet-guided laser technology — Laser MicroJet — the ILE 2400 enables manufacturers to effectively isolate the edge of PV cells to prevent short circuits. This inline, fully automated system is set to address the industry’s need for manufacturing tools aimed at improving solar cell efficiency and, ultimately, cell yield. This week, for the first time, the ILE 2400 is on display at the 22nd European Photovoltaic Solar Energy Conference (EU PVSEC) in Milan. The ILE 2400 will be production ready in Q4 2007, and Manz will be accepting orders for the system beginning December this year.

The ILE 2400 provides a new and alternative approach, primarily for solar cell edge isolation, with secondary applications including cutting and drilling. Edge isolation, a technique used to prevent parasitic shunts between the front- and back-sides of the cell, prevents short circuits to improve cell efficiency. Current technology approaches for the application include: plasma etching, conventional lasers and diamond saw blades. Each process, however, yields a set of limitations such as heat and silicon surface damage, as well as contamination caused by processing debris — all of which reduce cell integrity. Utilizing the Laser MicroJet approach, these factors are negligible given its gentle cooling and self-cleaning capabilities.

“Our active collaboration with Synova has led to a successful integration of its Laser MicroJet into our solar manufacturing platform, and we’re realizing the combined system’s increasing competitive technology benefits in terms of precision, throughput, and yield,” says Manz’s chairman of the board, Dieter Manz. “These benefits the ILE 2400 affords positively impact cell efficiency and overall manufacturing costs, and as demand for cost-effective equipment continues to heighten, we’re well-equipped to address our customers’ needs.”

Synova CEO Bernold Richerzhagen notes, “We’re excited to be working closely with Manz, and to be a part of enabling this emerging market with the introduction and development of this Laser MicroJet-integrated system. This licensing partnership — the first since our business model shift — is evidence of the versatility of Laser MicroJet’s abilities to enable improved manufacturing results across various industries.”

Richerzhagen adds, “We look forward to continued collaboration with Manz to explore Laser MicroJet’s application possibilities beyond edge isolation to discover new applications that will fully utilize our technology in the PV market.”

The development of the ILE 2400 follows on the heels of the Synova-Manz technology licensing partnership announced earlier this year. The partnership is solely dedicated to developing cost-effective manufacturing equipment for mono- and multi-crystalline solar cells that enables improved cell efficiency. Under the terms of the agreement, Synova will spearhead all R&D efforts, while Manz will drive the manufacturing, sales, and service operations on a worldwide and PV-exclusive basis. This licensing partnership is one of several Synova is establishing following a business model expansion beyond direct manufacturing and selling.

About Manz Automation
Manz Automation AG develops and manufactures systems and components for automation, quality assurance, and laser process technology. The core competencies of the business lie in the areas of robotics, image processing, laser technology, and control technology. Using these, Manz Automation AG unifies the combined know-how from basic technology areas in order to reach an optimal solution for its customers. The company is divided into divisions for photovoltaics (systems.solar), LCD (systems.lcd) as well as for components and OEM systems (systems.aico) for use in automation in various industries. In addition, Manz Automation AG plans in the future to also equip laboratory systems of the pharmaceutical and life science industries with its technology (system.lab). Manz Automation AG was established in 1987 and is based in Reutlingen, Germany, with agencies in the U.S., Taiwan, Korea, China, and Hungary. In fiscal year 2006, the Manz group earned revenues of approximately 44 million euros, almost 50% more than in the preceding year. More than 60% of the revenue came from abroad, especially from Asia. Since September 22, 2006, the shares of Manz Automation AG have been quoted in the Entry Standard of the Frankfurt Stock Exchange under ISIN DE000A0JQ5U3 and the stock number A0JQ5U.

About Synova
Founded in 1997, Synova is the world pioneer and patent holder of Laser MicroJet(R), a state-of-the-art water jet-guided laser technology that combines the advantages of a laser beam and water to address the exacting manufacturing specifications and low cost-of-ownership (CoO) requirements associated with volume production of semiconductors, flat-panel displays, photovoltaics (solar cells), medical instrumentation, and automotive devices. Thanks to this innovative technology, Synova is revolutionizing the engineering playing field and fast emerging as the ideal provider for high-precision laser applications in these core markets. Additionally, Synova is satisfying growing demand across diverse markets through strategic licensing partnerships with original equipment manufacturers (OEMs), end users, and R&D institutes. Headquartered in Lausanne, Switzerland, Synova is a privately held company with subsidiaries located in Hong Kong, South Korea, Japan, and the United States. Additional information about the company is available at www.synova.ch.

About Laser MicroJet(R)
Synova’s Laser MicroJet is a revolutionary cutting process combining a laser beam and a water jet, where a hair-thin water jet guides the laser beam onto the wafer. Utilizing the difference in the refractive indices of air and water, the technology behind Laser MicroJet creates a laser beam that is completely reflected at the air-water interface, similar in principle to an optical fiber. This lack of deviation is maintained through and beyond the work piece, facilitating the accurate cutting of porous or layered materials. Also, contrary to standard laser processing technology, the Laser MicroJet uses the water jet to cool the material surface for optimal protection against thermal damage. At the same time, water is used as a natural layer of protection to prevent deposition or contamination. Both of these surface protection features offer significant improvements to standard cutting processes that boost device yields.

Source: Synova SA