Contaminated
Saline and Heparin Pre-Filled Flush Syringes Cause
Serious Bacterial Infections
-
January 25, 2008: FDA Announces Nationwide Recall:
FDA
states, “This type of bacterial infection
could present a serious adverse health consequence that
could lead to life-threatening injuries and/or death.”
-
Patients
and Doctors Are Warned to STOP USING THE PRODUCT
IMMEDIATELY!
On this Page:
Bacterial Contamination Causes Infections
All Heparin Lock Flush syringes
from Lot 070926H and Normal Saline Syringes
from Lot 070917A, have
been found to be contaminated with infection-causing Serratia
marcescens bacteria.
The
U.S. Centers for Disease Control and Prevention (CDC) has found
this dangerous bacteria in unopened heparin
syringes.
Types of
Infections
The Serratia marcescens bacteria
has been linked to:
- Pneumonia
- Blood infections
- Urinary
tract infections
- Wound infections
About 40 people
have been infected in Illinois and Texas, but the product has
been distributed in other states, including Colorado, Florida,
and Pennsylvania.
Twenty outpatients of the Rush University
Medical Center in Chicago became infected, and most required
hospitalization. They responded well to antibiotic treatment. No
deaths have been reported to date.
Symptoms
Infected patients
have reported becoming violently ill, with symptoms
including
vomiting, high fever, and chills.
One
30-year-old leukemia patient reported being hospitalized for
more than a week after developing an infection believed to be
linked to the use of a contaminated Sierra
Pre-Filled Syringe at home.
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FDA identifies the recalled brands
The contaminated syringes were manufactured
by AMT PAT, Inc., of Angier, North Carolina. All of these
syringes have the National Drug Code or NDC
Prefix of “64054.” They
have been distributed to both inpatient and outpatient facilities
as well as directly to patients for use at home.
BRAND NAME: Sierra
Pre-Filled, Inc.
PRODUCT DESCRIPTION:
- Heparin Lock Flush Solution USP, all strengths and sizes
- Normal Saline IV Flush Solution USP, all strengths and sizes
BRAND NAME: B. Braun Products
PRODUCT DESCRIPTION:
- Heparin Lock Flush - 10 units/mL 5mL in 12 mL Syringe
- Heparin Lock Flush – 100 units/mL 3mL in 12 mL Syringe
- Heparin Lock Flush – 100 units/mL 5mL in 12 mL Syringe
- Normal Saline IV Flush – 3mL in 12 mL Syringe
- Normal Saline IV Flush – 5mL in 12 mL Syringe
- Normal Saline IV Flush – 10 mL in 12 mL Syringe
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If you are a patient who used the recalled contaminated
syringes, you should:
- If you have used Sierra Pre-Filled or B.
Braun Heparin or
Saline Flush Syringes, either at home or in the hospital, and
if you have developed an unexplained systemic infection, you
should consult your doctor immediately for a full medical evaluation.
- If
you have any unused product on your shelves at home, secure
it in a place where it cannot be used, and return it to the
pharmacy or hospital where you obtained it. BE
SURE TO ASK FOR A RECEIPT, in case you should have to prove your exposure
to the contaminated syringes in the future.
- Tell your doctor that you have been exposed to syringes that have been recalled
by the FDA, even if you have not had symptoms of infection.
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Contact the injury attorneys of Kershaw, Cutter & Ratinoff
The personal injury attorneys of Kershaw,
Cutter & Ratinoff
have handled hundreds of cases involving dangerous and defective
medical products. In recent years, KCR
has litigated and settled numerous nationwide cases involving
such products as Intergel anti-adhesion surgical product, Guidant
defibrillators and pacemakers, and Phen-fen diet drugs. We have the specific
knowledge and experience to help our injured clients obtain fair
compensation in these complex cases.
If you or a loved one has
been exposed to the recalled contaminated
Heparin and Saline Pre-Filled Flush Syringes, and if you have developed an unexplained
systemic infection, you may be entitled to compensation for medical
treatment, hospitalization, lost wages, pain and suffering, and
other damages arising from your exposure.
Please click
here for a free case evaluation.
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Nationally recognized civil litigation attorneys
If
you are looking for attorneys with a proven record of success,
please call us toll-free at 888-285-3333 for
a free case evaluation. To find out more about our excellent
team of lawyers, visit our attorney
profiles.
Copyright © 2008 Kershaw, Cutter & Ratinoff LLP.
All Rights Reserved.
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FDA
update on ongoing investigation of contaminated
heparin products
FDA
Web site —
April
21, 2008
FDA
map of countries with contaminated Heparin products
FDA Web site — April
21, 2008
FDA
recalls contaminated syringes
United Press International — January
25, 2008
FDA
Warns Public of Contaminated Syringes
AM2 PAT, Inc., issues nationwide recall of all pre-filled syringe flushes
FDA Web site — January 25, 2008
FDA Recall
Statement:
Class
1 Recall: AM2 PAT Inc. Pre-Filled Heparin Lock Flush Syringes
and Normal Saline IV Flush Syringes (All Lots and All Sizes)
FDA Web site — December
20, 2007
RECALLS AT-A-GLANCE
BRAND NAME:
Sierra
Pre-Filled, Inc.
PRODUCT DESCRIPTION:
- Heparin Lock Flush Solution
USP, all strengths and sizes
- Normal Saline IV Flush Solution
USP, all strengths and sizes
BRAND NAME:
B.
Braun Products
PRODUCT DESCRIPTION:
- Heparin Lock Flush - 10 units/mL
5mL in 12 mL Syringe
- Heparin Lock Flush – 100
units/mL 3mL in 12 mL Syringe
- Heparin Lock Flush – 100
units/mL 5mL in 12 mL Syringe
- Normal Saline IV Flush – 3mL
in 12 mL Syringe
- Normal Saline IV Flush – 5mL
in 12 mL Syringe
- Normal Saline IV Flush – 10
mL in 12 mL Syringe
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