January 18, 2008
A North Carolina company earlier today issued a nationwide recall of heparin and saline pre-filled syringes.
The company had announced a recall of certain heparin syringes on Dec. 20. Today’s announcement is an expansion of that recall, which was issued because of possible contamination with Serratia marcescens, a bacterium.
The recalled syringes are labeled “Heparin Lock Flush Solution USP” or “Saline Lock Flush Solution USP” and contain one of the following NDC numbers on the barrel: 64054-1003-02, 64054-1003-01, 64054-3005-02, 64054-3003-02,
64054-0910-2, 64054-0905-2 or 64054-0903-2. NDC stands for National Drug Code.
Some of the recalled syringes have the company name “Sierra Pre-Filled.” Others, manufactured by Sierra, have the company name “B. Braun.”
People who have used the recalled syringes should contact their physicians for guidance.
Those who have unused syringes should not use them and should contact their physicians, pharmacies or other suppliers for instructions about what to do with them.
Physicians and others who have prescribed the recalled products are urged to contact their patients.
The recalled syringes typically are used in hospitals, clinics and by outpatients to keep catheters open. Heparin is an anticoagulant. The saline solution is used to clean the catheters.
AM2PAT Inc., doing business as Sierra Pre-Filled Inc., is voluntarily recalling the products in cooperation with the U.S. Food and Drug Administration.
Serratia marcescens is commonly found in soil and water and usually does not harm healthy humans but can cause illness in people with weakened immune systems or underlying health problems.
The company’s recall notice is available at: www.fda.gov/medwatch/safety/2008/heparin_recall.htm
(News Media: For more information contact Doug McBride, DSHS Press Officer, 512-458-7524.)