The Recall Desk
HighFDA (Devices)·Z-2780-2020·Announced 2020-08-19

Maquet Holder HKHZ 19 Recalled for Insecure Oxygenator Fit

Maquet is recalling Holder HKHZ 19 units for Quadrox-i and Quadrox-iD oxygenators because the holder may not securely hold the oxygenator.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect where the holder may not securely hold the oxygenator. This is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling 50 units of Holder HKHZ 19 (Model Number: 701047495, Lot Number: 70128207). This accessory is used with QUADROX i and QUADROX iD Neonatal / Pediatric oxygenators in cardiopulmonary bypass procedures for pediatric patients.

The recall was initiated because the Holder may not always snap and securely hold the oxygenator as intended. This defect could compromise the stability of the oxygenator during use.

The affected units were distributed worldwide, including in the United States (OH, PA, SC, CT) and in Germany, Spain, France, United Kingdom, Italy, United Arab Emirates, Mexico, Canada, Croatia, Georgia, Poland, Slovakia, Thailand, and Vietnam. Users should stop using the affected holders and contact Maquet Cardiovascular for further instructions.

The recalled product

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 QU
Manufacturer
Maquet Cardiovascular Us Sales, Llc
Category
Medical Device — Cardiopulmonary Bypass Accessories
Hazard
Affected units
50

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Related recalls

Same manufacturer · Maquet Cardiovascular Us Sales, Llc

See all →