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Terminated

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.

FDA Recall Z-2780-2020 · Posted None

Recalling FirmMaquet Cardiovascular Us Sales, Llc
Recall StatusTerminated
Product CodeKRI
Date Initiated2020-06-18
Date Terminated2022-12-30
Product Quantity50 units

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.

Firm Action

Getinge sent a customer letter dated July 2020 instructing customers to remove the affected products from areas of use and return the product(s) to Getinge following the provided instructions.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of OH, PA, SC, CT and the countries of Germany, Spain, France, United Kingdom, Italy, United Arab Emirates, Mexico, Canada, Croatia, Georgia, Poland, Slovakia, Thailand, and Vietnam.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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