Recall Z-1543-2008 ยท NZW Heparin, Vascular Access Flush
Medefil Incorporated
Medifil 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-fille
| Date | May 9, 2008 (initiated Mar 20, 2008) |
| Status | Terminated |
| Reason | The heparin lock flush solution was manufactured from contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API). The FDA has received reports of serious injuries and/or deaths in patients administered finished heparin injectable products manufactured from heparin API containing this contaminant. |
| Root cause | Material/Component Contamination |
| Action | Medefil telephoned the direct accounts on 3/20/08, e-mailed them a copy of the 3/20/08 recall letter on 3/21/08, and sent the accounts a hard copy of the recall letter on 3/24/08. The accounts were informed of Medefil's recall of 19 lots of Heparin I.V. Flush Syringes produced from the active pharmaceutical ingredient (API) Heparin Sodium, USP, lot 1035-0773, that has been recalled by the manufacturer, Scientific Protein Laboratories, due to the presence of a contaminant in the recalled lot of API. The accounts were instructed to stop use of the 19 lots of Heparin I.V. Flush Syringes immedia |
| Quantity | 3,151,080 syringes |
| Distribution | Class II Recall - Nationwide Distribution --- including states of Arizona, Florida, Illinois, Massachusetts, Pennsylvania, and Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.