Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD… recallZ-2780-2020 · Maquet Cardiovascular Us Sales, Llc · initiated Jun 18, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Cardiovascular Us Sales, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2780-2020
- Status
- Terminated
- Initiated by the company
- Jun 18, 2020
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Quantity
- 50 units
- Product code
- KRI
- 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.
Product description
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.
Code information (models, lots, serial numbers)
Model Number: 701047495 Part Number: HKHZ 19 UDI Code: 04037691533339 Lot# 70128207
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA Conv.kitMaquet Cardiopulmonary AG · ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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