FDA Device recall Z-1662-2019
Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01
- FDA Device
- Class II
- terminated
- Published 2019-06-05
On 2019-06-05 the FDA classified a Class II recall of Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01 by Maquet Cardiovascular, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1662-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-18 |
| Published | 2019-06-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Maquet Cardiovascular |
| Distribution | US |
Product
Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01
Reason
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
Identifiers
| code_info | Batch Numbers: 3000060743 3000066277 3000069078 3000073171 3000074176 3000076468 3000080999 3000081905 3000085277 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1662-2019%22
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