Sodium chloride injection bags recalled over potential flexible container leaks
Otsuka ICU Medical is recalling 509,360 100 mL bags of 0.9% Sodium Chloride Injection from one lot for lack of assurance of sterility due to potential flexible container leaks.
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: Scored 3 under the risk-of-harm criterion: a container leak compromising sterility in an intravenous solution creates an infection risk, and no injuries are reported.
Plain-English summary
0.9% Sodium Chloride Injection, USP, 100 mL, from ICU Medical of Lake Forest, Illinois, is being recalled for lack of assurance of sterility: potential for flexible container leaks.
The recall covers 509,360 100 mL bags from lot 1029921, expiring 28 February 2027, carrying NDC 0990-7984-37. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
A leak in the flexible container breaches the sterile barrier of a solution given directly into a vein. The enforcement record describes the loss of sterility assurance and reports no injuries.
Facilities holding lot 1029921 should quarantine it and follow the firm's instructions.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Otsuka ICU Medical LLC
- Category
- Drug — Intravenous solution
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 # 1029921
- Exp Date: 28 February 2027
Distribution
Distributed nationwide across the United States.
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