IV Flush Syringes and Irrigation Solutions Recalled for Sterility Defect
Nurse Assist, LLC recalls sodium chloride irrigation solutions and IV flush syringes due to potential lack of sterility assurance, which could allow contamination and infections.
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: This recall is classified as FDA Class I, which requires a minimum severity level of 4 per the rubric. The hazard involves potential lack of sterility in critical medical products. While no illnesses or infections have been reported in the source text, the potential for serious infection from nonsterile medical irrigation and IV flush solutions is significant.
Plain-English summary
Nurse Assist, LLC is recalling sodium chloride 0.9% irrigation solutions and IV flush syringes under multiple brand names (MAC MEDICAL, NURSE ASSIST, SOL, and HALYARD OWENS MINOR) due to potential lack of sterility assurance. The affected products may not be sterile and could result in contamination and infection when used.
The recall affects approximately 61,740 cases distributed nationwide across all U.S. states and territories, as well as Canada. The FDA has classified this as a Class I recall, indicating a serious health hazard.
If you have any of the affected products, stop using them immediately and contact Nurse Assist, LLC or your healthcare provider for instructions on return or disposal.
The recalled product
- Product
- 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP; SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001; HALYARD OWENS MINOR…
- Manufacturer
- Nurse Assist, LLC
- Affected units
- 61,740
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: 9210/20850020865042/21122520
- 21122573
- 22032938
- 1203-BP/B1501203BP4/22022797
- 1205-BP/B1501205BP4/22022789
- 23024788
- 1210-BP/B1501210BP4/21112359
- 21112384
- 21112388
- 21112441
- 21112451
- 21122519
- 21122550
- 21122588
- 21122614
- 22012632
- 22012669
- 22012668
- 22012672
- 22012673
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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