Injectable Sodium Chloride Recalled for Potential Container Leaks Compromising Sterility
ICU Medical is recalling 137,120 bags of 0.9% Sodium Chloride Injection because bags may leak and potentially compromise sterility. The affected lot (5829936) was distributed nationwide.
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 FDA Class II recall where bags may leak and compromise sterility, but no illnesses or injuries have been reported. Per the rubric, theoretical hazards without reported harm cannot exceed severity 3 (High).
Plain-English summary
ICU Medical Inc. is recalling 137,120 bags of 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bags. The affected lot is 5829936, with expiration date March 31, 2024.
The recall is due to lack of assurance of sterility. Bags have the potential to leak in the flexible containers, which may compromise sterility of the injectable solution.
The recalled bags were distributed nationwide in the USA.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- ICU Medical Inc
- Category
- Drug — Intravenous Solution
- Affected units
- 137,120
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)
- Lot: 5829936
- Exp. MAR 31 2024
Distribution
Distributed nationwide across the United States.
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