FDA Device recall Z-1728-2018
BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513 by Datascope, citing the Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1728-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-19 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Datascope |
| Distribution | AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, WA |
Product
BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
Reason
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Identifiers
| code_info | Lot 3000060036 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1728-2018%22
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