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 /
Check against the official notice below — it lists the full affected range.
Maquet Cardiovascular is recalling Holder HKHZ 19 accessories (model number 701047495, lot number 70128207) used with Quadrox-iD Pediatric Oxygenators. The holder is designed to snap and securely hold the oxygenator in place, but units in this specific lot may fail to secure properly. Fifty units were distributed worldwide, including to facilities in Ohio, Pennsylvania, South Carolina, Connecticut, and multiple international locations.
The recall affects only lot number 70128207 of this accessory product. The source document does not specify what actions affected consumers or healthcare facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: 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. Quantity: 50 units Lot/code info: Model Number: 701047495 Part Number: HKHZ 19 UDI Code: 04037691533339 Lot# 70128207
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.