Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal /… — Class II medical device recall Z-2780-2020
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2020-08-19, distributed nationwide. Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenato
| Recall number | Z-2780-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2020-06-18 |
| Classified | 2020-08-12 |
| Reported by FDA | 2020-08-19 |
| Terminated | 2022-12-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, DE, ES, FR, GB, HR, IT, MX, PL, SK, TH, VN |
| Quantity | 50 units |
| UPC / GTIN / UDI-DI | 04037691533339 |
| Lot numbers | 70128207 |
| Model numbers | 701047495 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2780-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.