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Warning About Contaminated Pre-Filled Syringes

FDA has announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.

These syringes are manufactured by AM2 PAT 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. The recall affects all lots of these products.

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 Centers for Disease Control and Prevention has confirmed growth of Serratia marcescens from unopened heparin syringes.

Serratia marcescens, a bacterium found in water and soil, has been linked to pneumonia, blood infections, and urinary tract and wound infections. Some patients exposed to the recalled syringes have developed blood infections.

Steps for Consumers and Health Care Facilities

Consumers and health care facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately.
Health care 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, such as a pharmacy or hospital.
Consumers also should let their health care providers know that they have been exposed to syringes recalled by FDA.
Consumers with questions may contact Sierra Pre-Filled at 919-552-9689, Monday through Friday, 10 a.m. to 5 p.m. EST.
Report any adverse reactions experienced with the use of the products, and/or quality problems to FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, M.D. 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

The Recalled Products

MANUFACTURER: Sierra Pre-Filled, Inc., Angier, N.C.
PRODUCT DESCRIPTION:
Heparin Lock Flush Solution USP, All Strengths and Sizes
Normal Saline IV Flush Solution USP, All Strengths and Sizes

Sierra Pre-Filled Inc. Products:

NDC #	CATALOG #	Product
64054-1003-02	1003-02	Heparin Lock Flush 100units/mL 5mL
64054-1003-01	1003-01	Heparin Lock Flush 100units/mL 3mL
64054-3005-02	3005-02	Heparin Lock Flush 10units/mL 5mL
64054-3003-02	3003-02	Heparin Lock Flush 10units/mL 3mL
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 IV Flush 10mL
64054-0905-2	0905-12	Normal Saline IV Flush 5mL
64054-0903-2	0903-12	Normal Saline IV Flush 3mL

B. Braun Products:

NDC #	CATALOG #	Product
64054-3005-02	513610	Heparin Lock Flush 10units/mL 5mL
64054-1003-01	513611	Heparin Lock Flush 100units/mL 3mL
64054-1003-02	513612	Heparin Lock Flush 100units/mL 5mL
64054-0903-2	513584	Normal Saline IV Flush 3mL
64054-0905-2	513586	Normal Saline IV Flush 5mL
64054-0910-2	513587	Normal Saline IV Flush 10mL

Date Posted: January 29, 2008

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