FDA Recalls Sterile Water and Saline Bottles for Sterility Assurance Issues
Nurse Assist, LLC is recalling sterile water and saline bottles across multiple brands due to potential lack of sterility assurance. The products could be nonsterile and may cause infection.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA classification is Class I. Per the severity rubric, Class I recalls receive a Critical designation. This medical device recall involves potential for serious infection from nonsterile solutions used in medical and clinical settings.
Plain-English summary
Nurse Assist, LLC is recalling sterile water and saline solutions distributed nationwide. The recall affects approximately 31,850 cases distributed across 40 U.S. states, Washington DC, Puerto Rico, and Canada. Products are sold under multiple brand names including Cardinal, Covidien, Haylard, IDEXX, McKesson, Medline, SteriCare, and Vyaire, as well as Nurse Assist's own Cardinal brand.
The products may lack adequate sterility assurance, potentially resulting in nonsterile items. Use of nonsterile water or saline solutions could cause infection.
Healthcare facilities and consumers should discontinue use of affected products. Specific product codes and lot numbers are available in the FDA recall notice to help identify affected items.
The recalled product
- Product
- Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE SALINE BOTTLE/1022, 100ML STERILE WATER BOTTLE/1024, 100ML STERILE WATER BOTTLE/10000, 100ML STERILE WATER BOTTLE/PT00103419, 100ML STERILE SALINE BOTTLE/PT001
- Manufacturer
- Nurse Assist, LLC
- Hazard
- sterility-failure
- infection-risk
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)
- Product Code/UDI-DI/Lot: 1020/50192253044490/21122619
- 22063546
- 22094023
- 22094028
- 22094074
- 22094095
- 22104138
- 23045320
- 23076080
- 1022/50192253044506/22012651
- 22063553
- 22083775
- 22093943
- 22094062
- 22104137
- 23045338
- 23076038
- 23076088
- 1024/50192253044513/21122618
- 22073561
Distribution
Distributed nationwide across the United States.
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