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

FDA device recall Z-1544-2008 · posted 2008-05-09 · Terminated

Recall details

Recalling firm

Medefil Incorporated

Reason for recall

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.

Action taken

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 immediately, place them under quarantine, and contact all customers to whom they further distributed the product, telling them to stop use of the product and return the product to Medefil through their supplier. The accounts were requested to complete and return to Medefil via fax 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

453,300 syringes

Distribution

Class II Recall - Nationwide Distribution --- including states of Arizona, Florida, Illinois, Massachusetts, Pennsylvania, and Texas.

Date initiated

2008-03-20

Date posted

2008-05-09

Date terminated

2010-04-15

Location

Glendale Heights, IL