Hospira announced a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection VisIV flex container following a confirmed customer report of particulate in a single unit.
The particulate was confirmed as human hair floating within the solution. If the foreign particulate breaks and passes through the intravenous (IV) catheter, it may result in local inflammation, phlebitis, allergic reaction, granuloma formation or microembolic effects, and/or low-level allergic response. Further, patients with preexisting trauma or other conditions that affects the microvascular blood supply are at an increased risk.
The affected lot is supplied in 250mL containers with Lot# 45-110-C6, NDC# 0409-7983-25, and and expiration date of 1MAR2016. The lot was distributed from December 2014–January 2015.
Sodium Chloride Injection is an injectable indicated as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures.
For more information call (800) 441-4100 or visit FDA.gov.