Heparin Syringe FDA Recall
AM2PAT Inc. manufactures these pre-filled syringes under both its private label, Sierra Pre-Filled Inc., as well as under the B. Braun Medical Inc. label.
[ January 18, 2008 ] — 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.
| Catalog # | Lot # | Description |
|---|---|---|
| 513584 | All | Normal Saline 3mL in 12 mL Syringe |
| 513586 | All | Normal Saline 5mL in 12 mL Syringe |
| 513587 | All | Normal Saline 10mL in 12 mL Syringe |
| 513610 | All | 10 units/mL Heparin, 5mL in 12 mL Syringe |
| 513611 | All | 100 units/mL Heparin, 3mL in 12 mL Syringe |
| 513612 | All | 100 units/mL Heparin, 5mL in 12 mL Syringe |
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.
Heparin Syringe Recall Lawsuit
If you or a loved one have suffered an injury and contracted the Serratia Marcescens bacteria after using Sierra Heparin Lock Flush Solution syringes, then you should contact us immediately to talk to a Board Certified Personal Injury Trial Lawyer, certified by the Texas Board of Legal Specialization. Nationwide Assistance is available and our consultation is free and confidential. Write us online or call us: Toll Free 1-800-883-9858.
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