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Nationwide Recall of Heparin Lot; Hair Contamination


Hospira, Inc., conducted a 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, used to maintain catheter patency. 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 the preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk.

 

Heparin Sodium Injection in 0.9% Sodium Chloride at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency. The root cause of the contamination has not been determined and is under investigation.

 

The affected lot bares the NDC number 0409-7620-03, Lot number 41-046-JT, and expiration date of 01NOV 2015. The affected lot was distributed nationwide between June 2014 and August 2014 to wholesalers/distributors, hospitals and pharmacies. Anyone with an existing inventory should stop use and distribution and quarantine the product immediately.

 

See the Recall

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

 

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