Baxter Recalls Sodium Chloride Irrigation Bags Due to Sterility Concerns
Baxter Healthcare is recalling 0.9% Sodium Chloride Irrigation bags because they may leak, potentially compromising sterility.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risks such as loss of sterility in medical products are categorized as Severe.
Plain-English summary
Baxter Healthcare Corporation is recalling 22,336 bags of 0.9% Sodium Chloride Irrigation USP (5000 mL). The product is a prescription-only irrigation solution manufactured in Deerfield, Illinois.
The recall was initiated because the product has the potential to leak, which creates a lack of assurance of sterility. The affected lots are Y309971 and Y309971A, with an expiration date of 6/30/2021. The product was distributed nationwide within the United States.
Healthcare providers and consumers should check their inventory for the specific lot numbers and expiration date listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Irrigation Solution
- Affected units
- 22,336
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 (3)
- Lot #: Y309971
- Y309971A
- Exp. date 6/30/2021
Distribution
Distributed nationwide across the United States.
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