medical Class II Updated 2020-08-19

Maquet Cardiovascular Us Sales, Llc recalls Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonata

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number: 701047495 Part Number: HKHZ 19 UDI Code: 04037691533339 Lot# 70128207
View official government recall

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