Z-1543-2008

Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock...

Name: Z-1543-2008 Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock...
Creator: Medefil Incorporated
Published: 2008-03-20
License: https://open.fda.gov/license/

Medefil, Inc. / initiated 2008-03-20 / Terminated / root cause: manufacturing process

FDA source

Medefil Incorporated began a recall of Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic... on 2008-03-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1543-2008
Status: Terminated
Initiated: 2008-03-20
Posted: 2008-05-09
Terminated: 2010-04-15
Recalling firm: Medefil, Inc.
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
Product code: NZW Heparin, Vascular Access Flush
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: 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

Product code NZW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)