Recall Z-0599-2011 ยท NZW Heparin, Vascular Access Flush
Medefil Incorporated
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-fille
| Date | Dec 10, 2010 (initiated Nov 1, 2010) |
| Status | Terminated |
| Reason | The heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API). |
| Root cause | Material/Component Contamination |
| Action | 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 un |
| Quantity | 1,996,500 syringes |
| Distribution | Nationwide Distribution --- including states of Arizona, California, Florida, Illinois, Ohio, Louisiana, Massachusetts, Michigan, Minnesota, New York, Texas, and Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092491 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES Medefil, Inc., Feb 3, 2010 |