Device product
ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
Z-0058-2021
Product summary
- Event
- Event 86423
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6225 units
- Official record key
device-enforcement:Z-0058-2021
Official wording
Reason: There have been reports of the suction catheter coming apart from the device assembly during use.
Code information: Model: DYNCPDS14T, Lots 06919010016 and 06919020016
Distribution pattern: 62 US consignees; 1 government consignee, 4 foreign consignees
Derived failure modes
-
Unknown
There have been reports of the suction catheter coming apart from the device assembly during use.