Published Date: 2008-01-22 18:00:13
Subject: PRO/EDR> Serratia marcescens, pre-filled syringes - USA: recall
Archive Number: 20080122.0267

SERRATIA MARCESCENS, PRE-FILLED SYRINGES - USA: RECALL
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Date: Fri 18 Jan 2008
Source: Drugs.com [edited]
<http://www.drugs.com/fda/heparin-normal-saline-pre-filled-syringe-flushes-12332.html>


AM2 PAT, Inc, notified healthcare professionals and patients of a
nationwide recall of all lots of both heparin and normal saline pre-filled
flushes. These products are distributed under 2 brand names, Sierra
Pre-Filled Inc and B. Braun. The products are sold in 3 ml and 5 ml sizes
for Heparin and 3 ml, 5 ml, and 10 ml 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. This type
of bacterial infection could present a serious adverse health consequence
that could lead to life-threatening injuries and/or death.

User facilities and consumers should stop using the product immediately,
quarantine remaining inventory, and return the product to their respective
distributor.

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[The information for this recall available at
<http://www.fda.gov/medwatch/safety/2008/heparin_recall.htm> includes:

"Manufacturer: Sierra Pre-Filled, Inc., Angier, North Carolina
Product: Heparin Lock Flush Solution USP, All Strengths and Sizes
Saline Lock Flush Solution USP, All Strengths and Sizes
All lots of:
NDC No. / Catalog No. / Product Brand Name
64054-1003-02 / 1003-02 / Heparin Lock Flush 100units/ml 5ml
64054-1003-01 / 1003-01 / Heparin Lock Flush 100units/ml 5ml
64054-3005-02 / 3005-02 / Heparin Lock Flush 10units/ml 5ml
64054-3003-02 / 3003-02 / Heparin Lock Flush 10units/ml 5ml
64054-3003-06/ 3003-06 / Heparin Lock Flush 10units/ml 3ml (6ml syringe)
64054-3005-06 / 3005-06 / Heparin Lock Flush 10units/ml 5ml (6ml syringe)
64054-0910-2 / 0910-12 / Normal Saline Flush 10ml
64054-0905-2 / 0905-12 / Normal Saline Flush 5ml
64054-0903-2 / 0903-12 / Normal Saline Flush 3ml
The firm voluntarily recalled these products after confirming bacterial
contamination in some end user samples of product code 1003-02, Lot
070926H. These products have been distributed nationwide.
It appears from an ongoing Food and Drug Administration (FDA) inspection of
AM2 PAT, Inc.'s facility that the firm is not in compliance with the
Quality System regulation and failed to have adequate controls to ensure
necessary sterility of its pre-filled syringes."

The total number of patients in Illinois, Texas, and Florida affected by
the contamination does not appear to have increased since the last posting.
The recall, however, has expanded from the original one. This heparin
product is manufactured by a different company from the one concerned in a
recent posting on ProMED-mail (Undiagnosed reactions, fatal, heparin - USA:
(FL), alert, recall 20080119.0242). - Mod.LL]

See Also

Undiagnosed reactions, fatal, heparin - USA: (FL), alert, recall 20080119.0242
2007
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Serratia marcesens, heparin syringe - USA (02): (FL) 20071222.4112
Serratia marcescens, heparin syringe - USA: (IL, TX), alert 20071220.4090
Serratia marcescens, hospital, neonatal - Honduras (S. Pedro Sula)
20070316.0931
2005
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Serratia marcesens, contaminated solution - USA (NJ): alert 20050320.0808

.................ll/mj/jw/sh


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