Injectable Sodium Chloride Solution Recalled Due to Sterility Concerns and Leakage
Fresenius Medical Care is recalling 0.9% Sodium Chloride Injection due to lack of sterility assurance from potential leakage. The nationwide recall affects injectable saline bags distributed in the United States.
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 a Class II recall involving a high-risk injectable product with potential contamination due to lack of sterility assurance and leakage. No illnesses or injuries have been reported; however, the product poses significant risk of harm as non-sterile injectable solutions can cause serious infections.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling certain lots of 0.9% Sodium Chloride Injection, USP (0.9% saline), a sterile injectable solution used in medical settings. The recall was initiated due to lack of assurance of sterility resulting from potential leakage in certain product units.
The recall affects 4,097 cases containing 0.9% Sodium Chloride Injection packaged as 1,000 mL bags in 12-packs. Affected lot numbers are 22HU05062, 22HU06059, and 22HU05035 (expiration date 06/30/2023), and 22JU05001 (expiration date 07/31/2023). The product was distributed nationwide throughout the United States.
Healthcare facilities that received these lots should immediately discontinue use of the product. This is a Class II recall issued by the U.S. Food and Drug Administration.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Drug — Intravenous Solution
- Hazard
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 (6)
- Lot # 22HU05062
- 22HU06059
- 22HU05035
- EXP 06/30/2023
- 22JU05001
- EXP 07/31/2023
Distribution
Distributed nationwide across the United States.
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