Heparin and Saline Pre-Filled Syringe Recall


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Heparin and Normal Saline Pre-Filled Flushes Recalled

[Posted 01/18/2008] AM2 PAT, Inc., notified healthcare professionals and patients of a nationwide recall of all lots of both Heparin and Normal Saline pre-filled flushes. These products are distributed under two brand names, Sierra Pre-Filled Inc and B. Braun. The products are sold in 3ml and 5ml sizes for Heparin and 3ml, 5ml, and 10ml sizes for Normal Saline. One lot of Heparin IV flush syringes (1003-02, Lot 070926H) was contaminated with Serratia marcescens which has resulted in patient infections. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

User facilities and consumers should stop using the product immediately, quarantine remaining inventory, and return the product to their respective distributor.

If you or a loved one have suffered a serious infection as the result of a contaminated syringe, then please call us to discuss your legal rights to a potential product liability lawsuit. Please fill out our online form or call us right now:

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Heparin Syringe Recall

Heparin Lock Flush Solution syringes by Sierra may contain Serratia marcescens bacteria. Experts are warning anyone that has used Lot #070926H pre-filled Heparin Lock Flush Solution syringes to seek immediate medical attention if they develop a fever or other signs of infection.

Heparin Syringes Contaminated with Serratia Marcescens Bacteria

The Texas and Florida Departments of Health have announced that Lot #070926H Sierra Heparin Lock Flush Solution syringes used to flush IV and catheter lines to prevent clotting are being recalled due to the recent outbreak of blood infections associated with their use. The bacteria found in some of these pre-filled Heparin syringes in a known as Serratia marcescens. The recalled Heparin syringes by Sierra contain "Heparin Lock Flush Solution USP" and lot number 070926H on the packaging and on a yellow label affixed to the barrel of each syringe. Health officials urge people who have used the recalled syringes to contact their physicians for guidance.

What is a Heparin Injection?

Heparin is an anticoagulant, sometimes called a blood thinner. However, Heparin does not thin the blood or dissolve clots that have already formed. Instead, Heparin prevents clot formation and stops clots from getting bigger. Heparin helps to treat or prevent clots in the veins, arteries, lungs, or the heart, and to prevent clotting during open-heart surgery, dialysis, or in very sick patients who stay in bed.

These Heparin filled flush syringes that are part of this recall typically are used in hospitals and by outpatients to keep catheters and IV lines open. The recall was prompted by bacterial illnesses in Texas and other states since early November that were linked to the use of the product.

Additionally, experts are warning anyone that has used Lot # 070926H pre-filled Heparin flush syringes by Sierra to seek immediate medical attention if they develop a fever or other signs of infection. 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 by (Mail):

    Medwatch, HF-2FDA
    5600 Fishers Lane
    Rockville, MD 20852-9787

Return of Sierra Pre-filled Heparin Syringes

The FDA advises those who have used and/or unused syringes to not use them and to contact their physicians, pharmacies or other suppliers for instructions about what to do with them.

However, if you or a loved one has been become sick, developed a fever or been diagnosed with having the Serratia marcescens bacteria, then your should save the product and its packaging in a safe and secure place so that it can not be used, lost or discarded. If you have been injured or suffered an injury that can be linked to the Sierra pre-filled Heparin syringe, then the prefilled syringe and all packaging is part of your evidence in a potential product liability case.

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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