The voluntary removal affects the following B. Braun branded Pre-filled Heparin and Saline Flush Syringes manufactured by AM2PAT:
Catalog # Lot #
513584 All 513586 All 513587 All 513610 All 513611 All 513612 All
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. 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 replacement product.
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 and/or death.
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.
* Online: www.fda.gov/medwatch/report.htm * Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 * Fax: 1-800-FDA-0178
Contacts
Stern + Associates for B. Braun Medical Inc. Stephanie Euler, 908-276-4344 ext. 213 stephanie@sternassociates.com or B. Braun Medical Inc. Susan Denby, 610-997-4856 susan.denby@bbraun.com
