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.
What this means for you
Illness, injury, or structural failure has been reported. 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: 0
- Manufacturer
- Nurse Assist, LLC
- Hazard
- lack-of-sterility
- 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: 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
Distributed nationwide across the United States.
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