Device product
ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
Z-2725-2020
Product summary
- Event
- Event 85983
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 680 units
- Official record key
device-enforcement:Z-2725-2020
Official wording
Reason: There are reports of the suction catheter coming apart from the device assembly during use.
Code information: Model: DYNCPTP14T, Lot #6918100021:
Distribution pattern: US Nationwide distribution including in the states of AR, AZ, CA, FL, GA, IL, MS, NY, NV, OH, PA, TX.
Derived failure modes
-
Unknown
There are reports of the suction catheter coming apart from the device assembly during use.