Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion… — Class II medical device recall Z-0677-2020
Ongoing recall by GETINGE US SALES LLC, reported 2019-12-18, distributed nationwide. Sterile barrier system may be compromised
| Recall number | Z-0677-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GETINGE US SALES LLC, WAYNE, NJ, United States |
| Recall initiated | 2019-11-13 |
| Classified | 2019-12-12 |
| Reported by FDA | 2019-12-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 3,633 us |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 04037691670164 |
| Lot numbers | 70113694, 70114704, 7011472, 70120282, 70120283, 70120470, 70120471, 70121444, 70121445, 70121668, 70122004, 70123847, 70123849, 70123850, 70123852, 70123853, 70123854, 70124474, 70124525, 70124526, 70124527, 70124528, 70124529, 70124689, 70124691, 70124692, 70124693, 70124694, 70124695, 70124696, 70127335, 70127336, 70127498, 70127499, 70128623, 70129395, 70130216, 70131871 |
| Model numbers | 30000 |
Product
Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
Reason for recall
Sterile barrier system may be compromised
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-0677-2020. 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.