B. Braun Medical recalls saline flush syringes due to particulates

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


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