Device product
Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples, food bolus, and foreign bodies in the gastrointestinal tract.
Z-1771-2022
Product summary
- Event
- Event 90776
- Status
- Terminated
- Classification
- Class II
- Quantity
- 245 devices
- Official record key
device-enforcement:Z-1771-2022
Official wording
Reason: M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct.
Code information: UDI/DI 00816734021361, lot number 001919, 2024-10-31, shipped between 9-27-2021 and 10-22-2021.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct.