Official recall notice

FDA DrugClass IINotable

FDA Recall: 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethle

Recall date
2026-04-29
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Recommended action

What to do

124,244 bags

Product description

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Related Recalls