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Diversatek Health, M-Catch Retrieval Nets, Part Number REF… recallZ-1771-2022 · Diversatek Healthcare · initiated Oct 29, 2021

Class II Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Diversatek Healthcare or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Employee error

Recall details

Recall number
Z-1771-2022
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 29, 2021
Recalling firm
Diversatek Healthcare
Quantity
245 devices
Product code
FGX
Distribution
US Nationwide distribution.

Product description

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.

Code information (models, lots, serial numbers)

UDI/DI 00816734021361, lot number 001919, 2024-10-31, shipped between 9-27-2021 and 10-22-2021.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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