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U.S. Department of Health and Human Services

Class 2 Device Recall Diversatek Healthcare

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  Class 2 Device Recall Diversatek Healthcare see related information
Date Initiated by Firm October 29, 2021
Create Date September 19, 2022
Recall Status1 Terminated 3 on April 10, 2024
Recall Number Z-1771-2022
Recall Event ID 90776
Product Classification Snare, non-electrical - Product Code FGX
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.
Code Information UDI/DI 00816734021361, lot number 001919, 2024-10-31, shipped between 9-27-2021 and 10-22-2021.
Recalling Firm/
Manufacturer		 Diversatek Healthcare
102 E Keefe Ave
Milwaukee WI 53212-1535
For Additional Information Contact Laura L. Boll
414-755-4806
Manufacturer 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.
FDA Determined
Cause 2		 Employee error
Quantity in Commerce 245 devices
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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