FDA Recalls ICU Medical Saline Lot Due to Packaging Error

The FDA posted a recall notice for a specific lot of saline products manufactured by ICU Medical. The recall covers 0.9% Sodium Chloride Injection, USP, 100 mL, lot 1042188. This issue is the third potassium chloride packaging problem in ICU Medical's IV solutions line over 19 months. Some bags in the recalled overwrap may actually contain Potassium Chloride Injection 10 mEq.

The recall affects ICU Medical's product line because the packaging error involves mislabeling the contents of the bags. The pattern of packaging issues raises questions about quality control within the company's IV solutions.