FDA Device

Medefil Heparin I.V. Flush Syringe 100 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 100 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 followi

Hazard

The heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API).

What You Should Do

Remedy

Medefil faxed/emailed the direct accounts on 11/1/10, and sent the accounts a hard copy of the Urgent Product Recall letter, dated 11/1/2010, on 11/2/10. The accounts were informed of Medefil's recall of 18 lots of Heparin I.V. Flush Syringes produced from the active pharmaceutical ingredient (API) Heparin Sodium, USP, lot 1035-0780, that has been recalled by the manufacturer, Scientific Protein Laboratories, due to the presence of a contaminant, Oversulfated Chondroitin Sulfate. The accounts were instructed to stop use of the 18 lots of Heparin I.V. Flush Syringes immediately, place them under quarantine, and contact Medefil to arrange for the product to be returned. The accounts were requested to complete and return to Medefil the enclosed response form, indicating the quantity on hand of each recalled lot. Any questions were directed to Pradeep Aggarwal, President at 630-682-4600.

Products

Medefil Heparin I.V. Flush Syringe 100 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
Brand
Medefil Incorporated
UPC
a) catalog # MIH-3333: Lot H109298, exp. date 08/11; Lot H110152, exp. date 01/12; b) catalog # MIH-3335: Lot H109291, exp. date 08/11; Lot H109293, exp. date 08/11; Lot H109295, exp. date 08/11; Lot H109297, exp. date 08/11; H109299, exp. date 08/11; Lot H109300, exp. date 08/11.

Units Affected

1,996,500 syringes