Saline Solution Injection Recalled Nationwide Due to Sterility and Leakage
Fresenius Medical Care is recalling 0.9% Sodium Chloride Injection distributed nationwide due to lack of assurance of sterility and potential leakage. Multiple lot numbers with expiration dates ranging from May 2023 to August 2023 are affected.
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: This is an FDA Class II recall of an injectable pharmaceutical product with lack of sterility assurance and potential leakage. While the hazard poses significant risk of infection for injectable solutions, no illnesses or injuries have been reported. Per the severity rubric, this qualifies as a high-risk situation where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 0.9% Sodium Chloride Injection, USP, a sterile injectable saline solution distributed nationwide. The product is supplied in 1-liter bags, packaged in cases of 12 bags each. The recall affects approximately 16,006 cases.
The recall is being issued due to lack of assurance of sterility and potential leakage of the product. The affected lot numbers include 22EU05043 (expiration 5/21/2023), 22HU05018 (6/9/2023), 22HU05019 (6/10/2023), 22HU05025 (6/12/2023), 22HU05026 (6/12/2023), 22HU05049 (6/22/2023), 22HU05053 (6/24/2023), 22HU05054 (6/25/2023), 22HU05055 (6/25/2023), 22HU06027 (6/11/2023), 22HU06049 (6/23/2023), 22HU06055 (6/24/2023), 22HU06056 (6/25/2023), 22JU05008 (7/4/2023), 22KU06036 (8/19/2023), and 22JU06023 (7/8/2023).
The product was distributed nationwide in the USA. Healthcare facilities and providers who have received this product should verify they do not possess the affected lot numbers and should not use the product if the lot number matches one of the recalled batches.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Drug — Injectable / IV Solution
- Hazard
- Affected units
- 16,006
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 (20)
- Lot # 22EU05043
- EXP 5/21/2023
- 22HU05018
- EXP 6/9/2023
- 22HU05019
- EXP 6/10/2023
- 22HU05025
- 22HU05026
- EXP 6/12/2023
- 22HU05049
- EXP 6/22/2023
- 22HU05053
- EXP 6/24/2023
- 22HU05054
- 22HU05055
- EXP 6/25/2023
- 22HU06027
- EXP 6/11/2023
- 22HU06049
- EXP 6/23/2023
Distribution
Distributed nationwide across the United States.
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