FDA Device recall Z-1605-2019
Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133
- 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 46201 Small Pediatric Cardiac Surge Material: 709000133 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-1605-2019 |
| 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 46201 Small Pediatric Cardiac Surge Material: 709000133
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: 3000044424 3000046488 3000049459 3000055093 3000060357 |
|---|
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-1605-2019%22
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