Pre-filled heparin syringe recall due to risk of life-threatening infection

By Austin Kirk
Posted January 6, 2008

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Last month a nationwide heparin syringe recall was issued by AM2 PAT, Inc. for their Sierra pre-filled lock flush solutions. The heparin IV flush syringes were found to be contaminated with Serratia marcescens, which could cause serious and potentially life threatening infections. The lawyers at Saiontz & Kirk, P.A. are reviewing heparin syringe lawsuits for users of the recalled solution who have suffered a bacterial infection.

One lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL syringes), about 17,000 units, were recalled on December 20, 2007. The syringes were manufactured by Sierra Pre-Filled, Inc. of Angier, North Carolina and distributed throughout the United States. The recall applies to heparin syringes labeled with Lot #070926H, NDC #64054-1003-02 and Catalog #1003-02.

The pre-filled heparin syringes contain a blood thinner which is used to keep catheters open. They could be administered in a hospital or they could be prescribed for at home use. At least 40 serious infections have been reported among users of the contaminated heparin syringes and the CDC has confirmed that Serratia marcascens was present in several unopened syringes from this lot.

The Serratia marcescens bacteria could result in an infection which may cause serious injury or death. Symptoms of problems with the prefilled heparin syringes could include:

• Fever
• Chills
• Shaking
• Vomiting

HEPARIN SYRINGE LAWSUITS

According to an on-going FDA investigation, the facility which manufactured the heparin syringes appears to have not been in compliance with quality regulations and did not have adequate controls to ensure that the pre-filled heparin syringes were sterile. Patients rely on pre-filled syringes to be a sterile product, and as a result of the contaminated Sierra Pre-Filled Heparin Lock Flush Solution, users were exposed to an unneccessary risk of potentially fatal injury.

If you, a friend or family member suffered a serious infection after use of a prefilled heparin syringe, request a free consultation and claim evaluation.