Z-2780-2020Class II

Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number...

Name: Z-2780-2020 Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2020-06-18
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2020-06-18 / Terminated

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of 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... on 2020-06-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2780-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-18
Posted: 2020-08-12
Terminated: 2022-12-30
Recalling firm: Maquet Cardiovascular Us Sales, LLC
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 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.
Product code: KRI Accessory Equipment, Cardiopulmonary Bypass
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.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 50 units
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 codes and lots: Model Number: 701047495 Part Number: HKHZ 19 UDI Code: 04037691533339 Lot# 70128207

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2780-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2780-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-12

Product code KRI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)