Class II
Ongoing
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
- Company
- Otsuka Icu Medical Llc
- Recall Initiated
- October 27, 2025
- Posted
- November 5, 2025
- Recall Number
- D-0143-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 509,360 100 mL bags
- Firm Location
- Austin, TX, United States
Reason for Recall
Lack of Assurance of Sterility: Potential for flexible container leaks.
Distribution
Distributed Nationwide in the USA.
Lot / Code Info
Lot # 1029921, Exp Date: 28 February 2027
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