CLASS II Device recall · Reported 19 Aug 2020 · FDA Enforcement Report
Holder HKHZ 19 for use with Quadrox-i recalled
Maquet Cardiovascular Us Sales is recalling Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, distributed nationwide in the US. The recall was initiated on 18 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2780-2020
- FDA event ID
- 86020
- Recalling firm
- Maquet Cardiovascular Us Sales, Wayne, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jun 2020
- FDA classified
- 12 Aug 2020
- Reported
- 19 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 18 Jun 2020 | Recall initiated by company | |
| 12 Aug 2020 | Classified by FDA | +55 days |
| 19 Aug 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Why was it 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.
Which lots are affected?
Model Number: 701047495 Part Number: HKHZ 19 UDI Code: 04037691533339 Lot# 70128207
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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