Sterile Water and Saline Products Recalled for Lack of Sterility Assurance
Nurse Assist is recalling sterile water and saline irrigation products due to lack of sterility assurance. Use of nonsterile products could result in 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification indicates serious potential for adverse health consequences. Per the rubric, FDA Class I recalls cannot score below 4 (Severe). The hazard of infection from nonsterile medical products is significant, though no illnesses have been reported in the source text.
Plain-English summary
Nurse Assist, LLC is recalling sterile water for irrigation and sodium chloride irrigation (saline) products packaged in 120 mL cups with foil lids. These products may lack sterility assurance and could be nonsterile, potentially causing infection in patients who use them.
The affected products are CUP STERILE WATER (product code T167005) and CUP STERILE SALINE (product code T167007). A total of 432 cases have been distributed nationwide throughout the United States and to Canada.
Patients and healthcare providers who have these products should discontinue use. Anyone who has used a potentially nonsterile product should seek medical attention if symptoms of infection develop, including fever, redness, swelling, or drainage at the site where the product was used.
The recalled product
- Product
- Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID 120 ML/T167007
- Manufacturer
- Nurse Assist, LLC
- Affected units
- 432
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 (9)
- Product Code/Lot: T167005/22022859
- 22083878
- 23055524
- T167007/21122503
- 22022860
- 22083862
- 22114365
- 23045255
- 23045267
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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