Heparin Product Recall and Injuries

[Mrs. Sharon B. Hodge]

Heparin Product Recall and Injuries

Anti-Coagulant Injection Products Linked to Side Effects

Patients all over the world need medical care in the form of dialysis for kidneys, IV fluids for many reasons and other types of procedures designed to help them cope with existing problems or even to get past them. One of the challenges that medical professionals have faced when administering this care is preventing the body's natural reaction to any sort of open wound, which is to immediately manufacture substances that lead to clotting.

Several products on the market have been available to help slow or prevent this clotting in order to promote a more efficient administration of the treatments needed, and according to news published on the FDA's Web site, a few of these anti-coagulant products and the syringes in which they're packaged have been recalled due to their link to the development of serious side effects.

Pre-Filled Flushes Recalled

AM2 PAT, Inc. is the manufacturer of both Heparin and Normal Saline pre-filled flushes, and these products are known by the brand names of 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. Serratia marcescens is a bacterium that can cause urinary tract infections and even carries a significant mortality rate if it goes undetected.

Baxter Healthcare Corporation

Baxter manufactures and distributes the products generally known as multi-dose and single-use vials of heparin sodium for injection and heparin lock flush solutions. These products have been voluntarily recalled because of the tendency in patients to show several troubling side effects:

Oral swelling
Nausea
Vomiting
Organ failure
Shock
Shortness of breath
Severe hypotension
Death
Most reported cases have involved an almost immediate development of these side effects, but the FDA, in its announcement of the recall and investigation of the cause of this issue, specifically did not rule out the possibility that these potentially severe side effects could develop at a later time.