FDA Warns Public
of Contaminated Syringes
[Posted 02/08/2008]
The
US Food and Drug Administration (FDA) announced on
January 29 a nationwide recall of all lots of
heparin and saline pre-filled flush syringes
manufactured by AM2 PAT, Inc. of Angier, NC. Two
lots have been found to be contaminated with
Serratia marcescens, a bacterium that can cause
serious injury or death. AM2 PAT manufactured the
syringes under the brand names Sierra Pre-filled,
Inc. and B. Braun. They are sold in fill sizes of
3mL, 5mL, and 10mL and syringe sizes of 6mL and
12mL.
Consumers and healthcare facilities with any of the
recalled, pre-filled Heparin Lock or Normal Saline
IV Flush syringes should stop using the products
immediately, states the FDA. Healthcare facilities
should immediately quarantine the products in their
inventory and return them to their distributor.
Individual consumers should return them to the
location from which they were received, and let
their healthcare providers know that they have been
exposed to syringes recalled by FDA.
The
recall affects all lots of these products. The FDA
received information that Heparin Lock Flush
syringes from Lot 070926H and Normal Saline IV
syringes from Lot 070917A have been found to be
contaminated with Serratia marcescens, and have
resulted in patient infections. The US Centers for
Disease Control and Prevention has confirmed growth
of Serratia marcescens from unopened heparin
syringes. Traditionally, the bacterium is found in
water and soil and has been linked to pneumonia,
blood infections, and urinary tract and wound
infections. Some patients exposed to the recalled
syringes have developed blood infections.
AM2 PAT, Inc. voluntarily recalled these products
on January 18 after confirming bacterial
contamination in some user samples. Consumers with
questions may contact Sierra Pre-filled at
919.552.9689, Monday through Friday, 10 a.m. to 5
p.m. EST. For a complete listing of the products
recalled, including their NDC and catalog numbers,
visit http://www.fda.gov/bbs/topics/NEWS/2008/NEW01785.html.
Any adverse reactions experienced with the use of
the products, and/or quality problems should also
be reported to the FDA’s MedWatch Program by phone
at 800.FDA.1088, by fax at 800.FD.-0178, by mail at
MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville,
MD 20852-9787, or on the MedWatch website at
http://www.fda.gov/medwatch/.
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