FDAJune 18, 2020device

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...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

maquet cardiovascular us salesmaquetmaquet cardiovascular

UPCs

04037691533339

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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