FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
Consumer Update |
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.
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
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 |
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