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Heparin Alert From The FDA!

Posted Aug 24 2008 4:41pm
There are many people all over the world who 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.



Medical professionals are concerned when administering this care they

need to prevent the body's natural reaction to any sort of open wound,

which is to immediately manufacture substances that lead to clotting.



There are several products on the market that helps slow or prevent

this clotting. 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 hypertension

Death




Most reported cases have involved an almost immediate development of

those side effects.



The FDA announced the possibility that these potentially severe side

effects could develop at a later time.
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