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Hair in IV Sodium Chloride Solution; Nationwide Recall


Hospira, Inc., is conducting a nationwide recall of one lot of  0.9% Sodium Chloride Injection, USP, 250 mL (NDC 0409-7983-02, Lot 44-002-JT, Expiry 1AUG2016) to the user level due to one confirmed customer report of particulate in a single unit. Hospira identified the particulate as a human hair, sealed in the bag at the additive port area.

 

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 a preexisting condition such as trauma or other medical conditions that adversely affect the microvascular blood supply are at an increased risk.

 

This lot was distributed nationwide from September 2014 through November 2014. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.

 

Use of any existing inventory of the recalled lot should be stopped, and the product quarantined immediately.

 

See the Recall

 

See also Medical Law Perspectives, March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks

 

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

 

See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe

 

 

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