Manufacturers of sterile medical products are supposed to follow strict sterility standards. Unfortunately, there has been a growing number of reports and recalls of contaminated medical products caused by poor quality controls by manufacturers of products required to be sterile. The latest recall involves heparin IV flush syringes found to be contaminated with Serratia marcescens, a potentially dangerous bacteria. The details of this heparin syringe recall are as follows:
Manufacturer: Sierra Pre-Filled, Inc., Angier, North Carolina
Recall initiated by: AM2PAT, Inc., Angier, North Carolina
Product Description: Heparin Lock Flush Solution USP, 100 units/ml, 5ml in pre-filled syringes
Lot #: 070926H
The product was distributed nationwide. One may ask, “why worry about bacterial contamination in a supposedly sterile solution?” The answer is that bacteria such as the kind the CDC confirmed was growing in this lot of heparin syringes can cause serious health consequences that could lead to life-threatening injuries and death. One such adverse health risk is systemic inflammatory response syndrome (SIRS), which results in inflammation throughout the whole body and can lead to death. A cause of SIRS is exposure to high levels of endotoxins, such as those produced by certain bacteria as the bacteria dies.
Any adverse reactions experienced after heparin therapy should be reported to the FDA’s MedWatch Program at 1-800-FDA-1088 (phone), 1-800-FDA-0178 (FAX), www.fda.gov/medwatch (web), or Medwatch, HF-2FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 (mail).
If you or a loved one has been injured by this product, do NOT return the product to the manufacturer. For more information, please feel free to contact us through the Ask a Lawyer feature on this blog site.