FDA Device recall Z-0057-2017
The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide complia…
- FDA Device
- Class III
- terminated
- Published 2016-10-19
On 2016-10-19 the FDA classified a Class III recall of The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide complia… by Circulatory Technology, citing twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0057-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-07-01 |
| Published | 2016-10-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Circulatory Technology |
| Distribution | US |
Product
The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
Reason
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
Identifiers
| code_info | Lot Numbers: R19229, 015323, 014882, 014602 & 014601 |
|---|
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-0057-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.