Class 2 Device Recall Heparin I.V. Flush Syringe 100 units/mL

• Date Initiated by Firm: March 20, 2008
• Date Posted: May 09, 2008
• Recall Status: Terminated on April 15, 2010
• Recall Number: Z-1543-2008
• Recall Event ID: 47378
• Product Classification: Heparin Access Flush - Product Code NZW
• Product: 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-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations:; a) NDC #64253-333-35, catalog #MIH-3335: 5 mL fill in 12 mL syringe ; b) NDC #64253-333-33, catalog #MIH-3333: 3 mL fill in 12 mL syringe ; c) NDC #64253-333-23, catalog #MIH-3323: 3 mL fill in 6 mL syringe
• Code Information: a) catalog #MIH-3335: lot H107301, exp. date 09/09; H107305, exp. date 09/09; H107309, exp. date 10/09; H107313, exp. date 10/09; H107317, exp. date 10/09; H107322, exp. date 10/09; H107340, exp. date 11/09; H108111, exp. date 12/09; H108116, exp. date 12/09; H108122, exp. date 01/10; H108127, exp. date 01/10; b) catalog #MIH-3333: lot H107332, exp. date 11/09; H108106, exp. date 12/09; H108118, exp. date 12/09; c) catalog #MIH-3323: lot H108117, exp. date 12/09
• Recalling Firm/ Manufacturer: Medefil Incorporated; 250 Windy Point Dr; Glendale Heights IL 60139-3805
• For Additional Information Contact: Mr. Pradeep Aggarwal; 630-682-4600
• Manufacturer 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.
• FDA Determined 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 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.
• Quantity in Commerce: 3,151,080 syringes
• Distribution: Class II Recall - Nationwide Distribution --- including states of Arizona, Florida, Illinois, Massachusetts, Pennsylvania, and Texas.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.