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. (Read about the AM2Pat Inc. Heparin Recall.) This recall has prompted B. Braun Medical to recall its affected products, which includes the following Heparin syringes and normal saline flush syringes:

• Normal Saline 3mL in 12 mL Syringe, Catalog #513584
• Normal Saline 5mL in 12 mL Syringe, Catalog #513586
• Normal Saline 10mL in 12 mL Syringe, Catalog #513587
• 10 units/mL Heparin, 5mL in 12 mL Syringe, Catalog #513610
• 100 units/mL Heparin, 3mL in 12 mL Syringe, Catalog #513611
• 100 units/mL Heparin, 5mL in 12 mL Syringe, Catalog #513612
  

Customers that have the recalled product in their possession should discontinue use immediately. 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.

We are investigating cases involving Heparin products. To contact a lawyer at Pritzker | Ruohonen, please call toll-free at 1-888-377-8900 or submit the firm's free case consultation form.

Labels: B. Braun Heparin Syringe Recall, B. Braun Recall, Serratia marcescens