Class 2 Device Recall Diversatek Healthcare

• Date Initiated by Firm: October 29, 2021
• Create Date: September 19, 2022
• Recall Status: Terminated 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.
• FEI Number: 2183446
• 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: 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.