January 22, 2008 — / FDA / — B. Braun Medical, Inc. was recently notified by its contract manufacturer, AM2PAT, Inc., of a nationwide recall of all lots and sizes of pre-filled heparin and saline flush syringes. Customers that have the recalled product in their possession should discontinue use immediately. If patients report any problems that may be related to usage of this product a physician should be contacted.
Based on ongoing FDA inspection of AM2PAT, Inc.’s facility and CDC investigation, it has been determined that there is a potential for the sterility of these affected products to be compromised, which may result in potential contamination. AM2PAT previously initiated a recall of one lot of Sierra pre-filled heparin (lot #070926H) that was found to be contaminated with Serratia marcescens, which may lead to patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product in this specific AM2PAT lot. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries or death.
Customers 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 a replacement product. 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.