Prefilled syringe heparin flush recall

By Austin Kirk
Posted April 2, 2008

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Yet another heparin recall was issued today, this time for prefilled heparin flush syringes manufactured by Covidien. Certain lots of the Monoject Prefill Heparin Lock Flush Syringes were recalled due to fears that they may be contaminated with the same fake ingredient which has led to severe allergic-type reactions associated with other forms of heparin. The lawyers at Saiontz & Kirk, P.A. are reviewing potential prefilled syringe heparin lawsuits for any individuals who have experienced problems which may be related to the heparin flush.

>>INFORMATION: Heparin Recall Lawsuits

Covidien, which was formerly known as Tyco Healthcare, initiated the prefilled syringe recall after they were notified by their supplier, Scientific Protein Laboratories LLP, that two lots of Heparing Sodium USP Active Pharmaceutical Ingredient provided by them may be contaminated with a heparin-like ingredient.

A factory owned by Scientific Protein Laboratories in China has been the center of controversy recently, as the FDA has identified a fake chemical ingredient originating at the plant which was used in heparin sold throughout the United States. Nearly 1,000 reports of severe allergic reactions have been received by the FDA, leading to a nationwide Baxter Heparin recall earlier this year. Other heparin recalls have been issued outside the United States as a result of the ingredients received from this same Chinese factory.

Although Covidien indicates that they are unaware of any adverse event related to their product, other Heparin injectable products containing the fake ingredient have been associated with serious injury and death.

The prefilled syringe heparin flush recall applies to the following products:

• Monoject PreFillTM 10U/mL Heparin Lock Flush Syringe, 10mL (Lots 7082274 and 7113214)
• Monoject PreFillTM 10U/mL Heparin Lock Flush Syringe, 3mL (Lots 7051524 and 7113214)
• Monoject PreFillTM 10U/mL Heparin Lock Flush Syringe, 5mL (Lots 7051524, 7082274, 7113164 and 7113174)
• Monoject PreFillTM 10U/mL Heparin Lock Flush Syringe, 2.5mL in 3mL syringe (Lot 7051444)
• Monoject PreFillTM 10U/mL Heparin Lock Flush Syringe, 5mL, with BLUNTIP plastic cannula (Lot 7082274)
• Monoject PreFillTM 100U/mL Heparin Lock Flush Syringe, 10mL (Lot 7113064)
• Monoject PreFillTM 100U/mL Heparin Lock Flush Syringe, 3mL (Lots 7041194, 7072154, 7113034 and 8010194)
• Monoject PreFillTM 100U/mL Heparin Lock Flush Syringe, 5mL (Lots 7041194, 7102804, 7041204, 7113034, 7051534, 7113044, 7051544, 7113054, 7051554, 7113104, 7071924, 7113114, 7072034, 7113154, 7072044, 8010064, 7072054, 8010114, 7072064, 8010134, 7072154, 8010174 and 7082284)
• Monoject PreFillTM 100U/mL Heparin Lock Flush Syringe, 5mL, with BLUNTIP plastic cannula (Lots 7051524 and 7113214)

Symptoms of the severe allergic reactions which could be caused by the prefilled heparin syringes include: low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.

This is the second Prefilled Heparin Syringe recall issued this year. In January 2008, Sierra Prefilled Lock Flush Solution containing heparin and sodium were recalled after they were found to be contaminated with Serratia marcescens. This contamination was different than the fake ingredient associated with the Baxter recall and the Covidien recall. The use of the Sierra Prefilled heparin Syringes has been associated with a risk of serious and potentially life threatening bacterial infections.

>>INFORMATION: Sierra Prefilled Heparin Syringe Lawsuits

HEPARIN LAWSUITS

The product liability lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing potential heparin lawsuits as a result of problems associated with any of the recently recalled products. Although most individuals are unaware of the exact heparin used, our lawyers can review the circumstances surrounding the injury to help determine if problems may be associated with contaminated heparin.

If you, a friend or family member have suffered a severe allergic reaction or a bacterial infection after receiving heparin or using a prefilled heparin syringe, request a free consultation and claim evaluation.