Sodium Chloride Injection Recalled Due to Storage Temperature Exposure Risk
Fresenius Medical Care is recalling Sodium Chloride 0.9% Injection due to potential storage temperature exposure that may compromise sterility. The affected product includes 53,424 bags distributed to clinics in South Carolina, North Carolina, and Virginia.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a sterile injectable with potential compromised sterility due to storage temperature exposure. No illnesses or injuries reported. Meets Score 3 criteria: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling Sodium Chloride 0.9% Injection, USP in 1000 mL bags. The recall affects 53,424 bags distributed to 32 clinics located in South Carolina, North Carolina, and Virginia. The affected lots are 23AU05030 (expiration 01/13/2024) and 23AU05035 (expiration 01/15/2024).
The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. This exposure creates a potential lack of assurance of product sterility.
Patients who may have received this product should consult their healthcare provider. Healthcare facilities should stop using the affected product immediately and contact Fresenius Medical Care Holdings, Inc. for further instructions.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Drug — Sterile Injectable
- Affected units
- 53,424
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 (4)
- Lot # 23AU05030
- Exp 01/13/2024
- 23AU05035
- Exp 01/15/2024
Distribution
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