Device Recall Heparin I.V. Flush Syringe 1 units/mL

a) catalog # MIH-4422: Lot H210209, exp. date 04/12; Lot H210238, exp. date 05/12; Lot H210265, exp. date 05/12; b) catalog # MIH-4425: Lot H210210, exp. date 04/12; H210241, exp. date 05/12.

General Hospital and Personal Use Devices

2

No

Nationwide Distribution --- including states of Arizona, California, Florida, Illinois, Ohio, Louisiana, Massachusetts, Michigan, Minnesota, New York, Texas, and Virginia.

Medefil Heparin I.V. Flush Syringe 1 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 1 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc. Glendale Heights, IL 60139. The pre-filled syringes were packed as 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC# 64253-444-22, catalog # MIH-4422: 2 mL fill in 6 mL syringe; b) NDC# 64253-444-25, catalog # MIH-4425: 5 mL fill in 6 mL syringe