FDA Warning: List of Medical Devices & Diagnostic Products that May Contain Heparin

Paul Kiesel

Attorney
(866) 735-1102 Ext 385

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Over the past year, Heparin, a widely used injectable anticoagulant, has come under intense scrutiny from consumer protection groups and the Food and Drug Administration.

In December 2007, the FDA recalled a shipment of heparin because of a growth of Serratia marcescens in several unopened syringes of this product. Serratia marcescens is a bacterium that can lead to life-threatening injuries and/or death.

Only six months ago, major recalls of heparin were announced by the FDA due to contamination of the raw heparin stock imported from China. The FDA released a statement that revealed the contaminated heparin killed at least 81 people in the U.S.

The most high-profile instance of negligent heparin overdose occurred in November 2007, when actor Dennis Quaid's twelve-day-old twins were accidentally given an adult dosage of the drug (the adult dosage was 1,000 times the recommended dosage for infants). The Quaid family subsequently sued the manufacturer of the product, Baxter Healthcare Corp., for over $50,000, due to confusing labeling and design that made the adult and infant versions of the product difficult to differentiate.

And, just this past summer, in July, another set of twins born at a Texas hospital died after an accidentally administered overdose of the drug.

Thus, the FDA updated its heparin recall list to include medical devices and diagnostic products that may contain or be coated with heparin. The FDA does not mean to suggest that all of the products herein have been or are affected by contaminated heparin, but its purpose is to warn consumers of potential products and devices that could be life-threatening if they contain contaminated heparin.

Also, as several other cases arose of people falling ill or dying due to products that contained or were coated with contaminated heparin (i.e another instance that involved Baxter International and one of its suppliers, a company that spun off from Oscar Meyer; the connection: pigs naturally produce proteins used in pharmaceuticals.), the FDA felt it was necessary to include companies that have otherwise yet to receive a complaint or have been forced to recall their products, due to the diversity in suppliers of heparin and its widespread usage.

Below is the FDA list warning consumers to be cogent of the products being administered to them and/or used. If any one has used one or more of these products over the past year and (s)he is concerned with short- or long-term affects, contact Mr. Paul R. Kiesel or Ms. Helen Zukin at (310) 854-4444.

FDA HEPARIN PRODUCT WARNING LIST: