Sterile Water Syringes recalled for lack of sterility assurance
Nurse Assist LLC recalls sterile water injection and irrigation syringes for inadequate sterility assurance. Affected products may be nonsterile and could cause infection if used.
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 medical device classification requires a minimum severity of 4 (Severe) per FDA rules. No deaths or serious injuries have been reported.
Plain-English summary
Nurse Assist LLC is recalling multiple formulations of USP Sterile Water Syringes, including products with codes 1030A, 6496722, 6496723, 1030, 51638, 52333, and 1010. The recall affects 15,800 cases distributed throughout the United States and to Canada, with multiple specific lot numbers identified in FDA recall notice Z-0515-2024.
The products are being recalled because they may lack adequate sterility assurance, which could allow nonsterile products to be distributed and used. Use of nonsterile irrigation or injection solutions could result in serious infection.
The recalled product
- Product
- Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/51638, 30CC PREFILLED SYRINGES/52333, 10CC PREFILLED SYRINGES/1010
- Manufacturer
- Nurse Assist, LLC
- Affected units
- 15,800
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: 1030A/B1501030A4/2001155
- 2003041
- 2005126
- 2008103
- 2102502
- 2102567
- 2102580
- 2102600
- 1812001
- 22032961
- 22114363
- 23014570
- 6496722/B15064967224/21081990
- 22012631
- 22012674
- 22012712
- 22022735
- 22012715
- 22022790
- 22022814
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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