B. Braun Recalls Sodium Chloride Irrigation Due to Particulate Matter
B. Braun Medical Inc. is recalling 17,360 units of 0.9% Sodium Chloride 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly for medical products where particulate matter poses a risk of harm.
Plain-English summary
B. Braun Medical Inc. is recalling 17,360 units of 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC). The product is identified by Catalog # R5200-01, NDC 0264-2201-00, Batch # J7N912, and an expiration date of 10/31/20. The affected units were distributed nationwide in the USA.
The recall was initiated following a customer complaint regarding the presence of particulate matter. The particulate matter was identified as polyethylene, which is consistent with the material used to manufacture the container cap.
This recall is classified as Class II by the U.S. Food and Drug Administration. Healthcare providers and patients should discontinue use of the affected product and contact B. Braun Medical Inc. for further instructions.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Irrigation
- Affected units
- 17,360
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)
- Batch # J7N912
- Exp 10/31/20
Distribution
Distributed nationwide across the United States.
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