ClearanceBrief
Recall Z-1771-2022 ยท FGX Snare, Non-Electrical

Diversatek Healthcare

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.

DateOct 29, 2021
StatusTerminated
ReasonM-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.
Root causeEmployee error
Quantity245 devices
DistributionUS Nationwide distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.