Medefil Heparin I.V. Flush Syringe 1 units/mL recallZ-0601-2011 · Medefil Incorporated · initiated Nov 1, 2010

Why it was recalled

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

FDA root cause category: Material/Component Contamination

What the company is doing

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.

Recall details

Recall number

Z-0601-2011

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Nov 1, 2010

Posted by the FDA

Dec 10, 2010

Recalling firm

Medefil Incorporated

Quantity

339,180 syringes

Product code

NZW

FDA submissions

K092491

Distribution

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

Product description

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

Other devices under the same FDA submission

3 devices cleared under K092491 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Heparin Lock Flush Syringe 10 Units/mL 3mL in 12mL syringe

  Medefil, Inc. · Heparin, Vascular Access Flush
  1 report
• Heparin Lock Flush Syringe 100 Unit/mL 3mL in 6mL syringe

  Medefil, Inc. · Heparin, Vascular Access Flush
  1 report
• Heparin Lock Flush Syringe 1 unit/mL 2 mL in 6mL Syringe

  Medefil, Inc. · Heparin, Vascular Access Flush
  1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 57096).

• Z-0599-2011 · Terminated
  Medefil 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…
• Z-0600-2011 · Terminated
  Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each …