Maquet Getinge- BEQ-T 9411 Lurie Children's 1/4 ADAPT… — Class II medical device recall Z-1679-2019
Terminated recall by Maquet Cardiovascular, LLC, reported 2019-06-05, distributed nationwide. Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented c
| Recall number | Z-1679-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2019-04-18 |
| Classified | 2019-05-30 |
| Reported by FDA | 2019-06-05 |
| Terminated | 2025-07-28 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, sterility |
| Lot numbers | 3000076765 |
Product
Maquet Getinge- BEQ-T 9411 Lurie Children's 1/4 ADAPT Material:709000485R01
Reason for recall
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
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-1679-2019. 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.