Halyard NEURO IR PERIPHERAL kit syringe adapter may disconnect
AVID Medical is recalling the Halyard NEURO IR PERIPHERAL (PS 64405) kit because the Medline syringe rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.
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: The source indicates this is an FDA Class I recall for a medical device with a potential risk of disconnection during use. Per the rubric, FDA Class I recalls are never scored below 4, and this structural/functional defect of a critical component meets the Severe threshold.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard NEURO IR PERIPHERAL (PS 64405) kit, Model Number UINR44-01. The syringe rotating adapter included in the kit may unwind during use, which could result in a loose connection or complete disconnection between the syringe and the manifold. This defect could compromise the integrity of the medical procedure.
The recall affects 204 kits distributed in the United States to facilities in Florida, Illinois, Missouri, Mississippi, North Carolina, Nebraska, and Texas. The affected kit lots are identified by the following UDI/lot numbers: 340135, 340136, 340352, and 349076.
Customers who have received this product should stop using it and contact AVID Medical, Inc. for instructions on return, replacement, or disposal. Healthcare providers should review their inventory and take the product out of service to prevent potential complications during use.
The recalled product
- Product
- Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 204
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 (3)
- (01)20809160484439(17)280201(10)340136(30)004(241)UINR44-01 (340136)
- (01)20809160454439(17)280201(10)340352(30)004(241)UINR44-01 (340352)
- (01)20809160484439(17)280201(10)349076(30)004(241)UINR44-01 (349076).
Distribution
Part of a larger recall action
This product is one of 10 recalled by AVID Medical, Inc. 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.
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