March 09, 2018
B. Braun Medical Inc. is recalling 17,360 plastic irrigation containers of 0.9% sodium chloride irrigation solution, USP, 1000-mL (NDC 0264-2201-00), according to the March 7, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recall was voluntarily initiated by the company February 16, 2018, after a customer found particulate matter in the product later identified as polyethylene, which is used to manufacture container caps.
The recall affects plastic irrigation containers from lot J7N912, which has an expiration date of October 31, 2020. Containers from the lot were distributed across the United States.
On February 27, 2018, the FDA designated the recall Class II, warning that of the affected irrigation containers could cause a temporary health problem. The probability of serious harm is remote.
Sodium chloride irrigation solution 0.9% is a prescription product used to clean tissues, wounds, and body cavities, and to irrigate catheters.
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