Halyard CARDIAC CATH PACK SAN23CARDQ Kit Syringe Adapter Risk
AVID Medical is recalling Halyard CARDIAC CATH PACK SAN23CARDQ kits (Model DRCC36) due to a Medline syringe rotating adapter that may unwind during use, potentially causing 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 FDA classified this as a Class I recall, which per the rubric mandates a minimum score of 4. The hazard involves potential device disconnection during a critical cardiac catheterization procedure, which poses significant patient safety risk.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard CARDIAC CATH PACK SAN23CARDQ kit (Model Number: DRCC36) distributed in the United States to Florida, Illinois, Missouri, Mississippi, North Carolina, Nebraska, and Texas. The recall was issued due to a potential risk that the Medline syringe rotating adapter may unwind during use.
If the adapter unwinds, the syringe and manifold may become loosely connected or fully disconnected. This disconnection could compromise the integrity of the procedure and patient safety.
A total of 180 kits are affected by this recall. The kit lot number is 1659651, and the UDI-DI is 10809160469088. Customers who have received this product should stop use immediately and contact AVID Medical, Inc. for further instructions.
The recalled product
- Product
- Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 180
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 (1)
- Model Number: DRCC36. UDI-DI (Kit Lot Numbers): 10809160469088 (1659651).
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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