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Recall Observatory FDA recall evidence

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

October 29, 2021

Class II

Product summary

Firm
Diversatek Healthcare
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

    reason.no_named_rule · v1.0.0

    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.