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U.S. Department of Health and Human Services

Class 2 Device Recall Heparin I.V. Flush Syringe 1 units/mL

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  Class 2 Device Recall Heparin I.V. Flush Syringe 1 units/mL see related information
Date Initiated by Firm November 01, 2010
Date Posted December 10, 2010
Recall Status1 Terminated 3 on February 13, 2012
Recall Number Z-0601-2011
Recall Event ID 57096
510(K)Number K092491  
Product Classification Heparin Vascular Access Flush - Product Code NZW
Product Medefil Heparin I.V. Flush Syringe 1 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 1 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 as 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC# 64253-444-22, catalog # MIH-4422: 2 mL fill in 6 mL syringe; b) NDC# 64253-444-25, catalog # MIH-4425: 5 mL fill in 6 mL syringe
Code Information a) catalog # MIH-4422: Lot H210209, exp. date 04/12; Lot H210238, exp. date 05/12; Lot H210265, exp. date 05/12; b) catalog # MIH-4425: Lot H210210, exp. date 04/12; H210241, exp. date 05/12.
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 with contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API).
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 339,180 syringes
Distribution Nationwide Distribution --- including states of Arizona, California, Florida, Illinois, Ohio, Louisiana, Massachusetts, Michigan, Minnesota, New York, Texas, and Virginia.
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.
510(K) Database 510(K)s with Product Code = NZW and Original Applicant = MEDEFIL, INC.
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