ICU Medical Recalls One Lot Of 0.9% Sodium Chloride Injection

(RTTNews) - ICU Medical, Inc. (ICUI) announced the recall one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container. 0.9% Sodium Chloride Injection, USP 1000 mL is an intravenous solution indicated for parenteral replenishment of fluid.

The recalled product lot was manufactured in the U.S. by Hospira, a Pfizer (PFE) company, on February 1, 2016 and was distributed nationwide to Hospira customers between April 14, 2016 and February 2, 2017.

ICU Medical noted that the reported incident was identified prior to use, and there have been no reports of adverse events associated with this issue to date.

Injection of particulate matter could potentially result in limited adverse events such as allergic reactions, local irritation and inflammation in organs or tissues, or other serious adverse health consequences.

Prior to administration, healthcare professionals, as instructed in the product labeling, should visually examine the product for particulate matter and discoloration and should discard if a defect is identified.