FDA recall Z-1771-2022

Diversatek Healthcare · Class II · 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.

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2021-10-29
Report date
2022-09-28
Termination date
2024-04-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Milwaukee, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1771-2022