Hospira has announced a voluntary nationwide user-level recall of one lot of Heparin Sodium, 1,000 USP Heparin Units/500mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500mL, due to a confirmed customer report of particulate in a single unit.
The particulate has been identified 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. Hospira states that in the unlikely event that the particulates pass through the intravenous catheter, local inflammation, phlebitis, and/or low level allergic response could occur. In particular, patients with a preexisting condition of trauma or other medical conditions that adversely affects the microvascular blood supply are at an increased risk.
The recalled products have NDC # 0409-7620-03, Lot #41-046-JT, and an expiration date of November 1, 2015. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle.
For more information call (800) 441-4100 or visit Hospira.com.