Halyard CATH LAB Kit Due to Syringe Adapter Disconnection Risk
AVID Medical is recalling the Halyard CATH LAB kit (Model SACL75-01) due to risk that a Medline syringe rotating adaptor may unwind during use, causing loose or complete 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 FDA classified this recall as Class I, which per the rubric requires a minimum severity score of 4 (Severe). Class I designations are reserved for situations where there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard CATH LAB kit, Model Number SACL75-01. The recall affects 172 kits distributed to Florida, Illinois, Missouri, Mississippi, North Carolina, Nebraska, and Texas.
A Medline syringe rotating adaptor included in the kit may unwind during use. This unwinding could result in a loose connection or complete disconnection between the syringe and the manifold, potentially compromising the integrity of the connection during medical procedures.
The FDA classified this as a Class I recall. Affected customers should stop using the product and contact AVID Medical, Inc. for further instructions regarding return or replacement of the affected kits. The specific lot numbers involved are identified by UDI codes (341730, 341742, 345855, and 345863).
The recalled product
- Product
- Halyard CATH LAB kit. Model Number: SACL75-01.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 172
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)20809160481377(17)280623(10)341742(30)004(241)SACL75-01 (341742)
- (01)20809160481377(17)280609(10)345855(30)004(241)SACL75-01 (345855)
- (01)20809160481377(17)280609(10)345863(30)004(241)SACL75-01 (345863).
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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