Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solut

FDA device recall Z-0600-2011 · posted 2010-12-10 · Terminated

Recall details

Recalling firm

Medefil Incorporated

Reason for recall

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

Action taken

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.

Root cause

Material/Component Contamination

Status

Terminated

Product code

NZW

Quantity affected

583,500 syringes

Distribution

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

Date initiated

2010-11-01

Date posted

2010-12-10

Date terminated

2012-02-13

Location

Glendale Heights, IL

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