Hospira announced a voluntary recall of one lot of 0.9% Sodium Chloride Injection due to particulate matter sealed in the bag at the additive port area. The particulate matter was identified as a human hair.
Although unlikely, the injection of particulate matter 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.
The affected lot is 44-002-JT with an expiration date of August 1, 2016 and was distributed nationwide from September 2014 through November 2014.
Sodium Chloride Injection is an injectable indicated as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures.
Hospira has notified customers not to use the product from the recalled lots and is arranging for the impacted product to be returned. Allocation credits and replacement products will be provided to contracted customers by Hospira.
For more information call (800) 422-9837 or visit the FDA Safety Alert page.