B. Braun Recalls Acetic Acid Irrigation Due to Particulate Matter
B. Braun Medical Inc. is recalling 2,576 containers of 0.25% Acetic Acid Irrigation USP due to the presence of polyethylene particulate matter.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves particulate matter (polyethylene) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
B. Braun Medical Inc. is recalling 2,576 containers of 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC). The product is identified by NDC 0264-2304-10, Lot # J7N965, and an expiration date of 10/31/2020.
The recall was initiated because of the presence of particulate matter in the product. The particulate matter was identified as polyethylene, which is consistent with the material used to manufacture the container cap.
The product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot and stop using the product if it matches the recalled description.
The recalled product
- Product
- ACETIC ACID (ACETIC ACID)
- Brand
- ACETIC ACID
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Irrigation Solution
- Hazard
- Affected units
- 2,576
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: J7N965
- Exp. 10/31/2020
Distribution
Distributed nationwide across the United States.
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