Recall Z-2780-2020— Maquet Cardiovascular Us Sales, Llc
Class II · Terminated
Class II FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2020-06-18, terminated 2022-12-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and QUADROX iD Neonatal / Pediatric Oxygenator and can also be used in combination with the holder's arm (016061) to use in cardiopulmonary bypass procedures (CPB) in a pediatric patient population.. Reason: Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hold the oxygenator as intended..
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-18
- Terminated
- 2022-12-30
- Firm location
- Wayne, NJ, United States
Product description
Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and QUADROX iD Neonatal / Pediatric Oxygenator and can also be used in combination with the holder's arm (016061) to use in cardiopulmonary bypass procedures (CPB) in a pediatric patient population.
Reason for recall
Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hold the oxygenator as intended.
Data sourced from openFDA. This site is unofficial and independent of the FDA.