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.
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: 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.
- Hazard
- device-disconnection
- adapter-malfunction
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
Distributed in 7 states:
- FL
- IL
- MO
- MS
- NC
- NE
- TX