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A Second Heparin
Recall
A second recall was
announced on January 25, 2008 on prefilled heparin and
saline syringes that have been manufactured by AM2 PAT,
Inc and distributed with brand names of Sierra Pre filled
Inc and B. Braun. The U.S. Food and Drug Administration
(FDA) reported that the two types of flushes were found
to be contaminated with Serratia Marcescens which is
a bacterium most commonly found in water and soil.
The first recall for
the same manufacture came December 20, 2007 with the
same contaminate. The FDA investigated the facility
where the syringes were manufactured and found that
the facility was not compliant with the Quality System
regulations to ensure sterility of the syringes.
The syringes are dispensed
in 3ml, 5ml and 10ml fill in 6ml and 12ml syringe sizes.
These syringes are typically used for the care and maintenance
of vascular access devices such as PICC Lines, triple
lumen central lines, medaports and peripheral IVs.
If you are maintaining
your vascular access device at home or work in a facility
that utilizes pre-filled syringes it is recommended
that you check the type of syringe and its manufacture.
If using the syringe distributed by the above the FDA
recommends the stop of use immediately, quarantine the
product, and notify health care provider or Administrator.
An associated web site
is www.fda.gov/medwatch.
References
(1) http: www.fda.gov, FDA News; FDA Warns Public
of Contaminate Syringes (AM2 PAT, Inc., issues nationwide
recall of pre-filled syringe flush.
The consumer health information
on this Website is for informational and educational
purposes only and is not a substitute for medical advice
or treatment for any medical conditions.
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