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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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…
- Manufacturer
- Nurse Assist, LLC
- Affected units
- 31,850
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
Part of a larger recall action
This product is one of 5 recalled by Nurse Assist, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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