Drug recall
The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the…
FDA recall event 74614 · Class III · Circulatory Technology Inc
Key facts
| Event ID | 74614 |
|---|---|
| Recall numbers | Z-0057-2017 |
| Recalling firm | Circulatory Technology Inc |
| Product type | Devices |
| Products | 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. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm. |
| Initiation date | Jul 1, 2016 |
| Report date | Oct 19, 2016 |
| Termination date | Apr 14, 2017 |
| City | Oyster Bay |
| State | NY |
| Country | United States |
| FEI number | 1000522036 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: