Hospira Heparin Sodium


Recall Number: #Voluntary
Date Published: September 11, 2014
Manufacturer: Hospira, Inc.

Hazards

  • Local inflammation
  • Phlebitis
  • Low-level allergic response

Summary by USRecalls.org

Hospira has issued a voluntary nationwide recall of one lot of Heparin Sodium due to the confirmed discovery of particulate that has been identified and confirmed by Hospira as human hair. If particle matter is present and passes through the intravenous catheter, it can result in local inflammation, phlebitis, and/or low-level allergic response.

FDA Official Description

Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary nationwide user-level recall of one lot of Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL, NDC 0409-7620-03 Lot 41-046-JT with expiration date of 01NOV 2015. This action is due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as human hair, sealed between the tube and the film at the round seal of the unused Administrative Port on the non-print side of the container.

In the unlikely event that the particulate breaks and pieces are able to pass through the intravenous catheter, injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response. Capillaries which may be as small as the size of a red blood cell, approximately seven microns in diameter, may become occluded. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk.

Products Affected

Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL, NDC 0409-7620-03 Lot 41-046-JT with expiration date of 01NOV 2015. 

What do I do next?

If you have inventory on the recalled lot of Heparin Sodium should stop use and distribution immediately. For questions call Stericycle at 1-855-201-4337 8am to 5pm ET, Monday through Friday.