Recall Z-1771-2022— Diversatek Healthcare
Class II · Terminated
Class II FDA medical device recall by Diversatek Healthcare, initiated 2021-10-29, terminated 2024-04-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Diversatek Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-10-29
- Terminated
- 2024-04-10
- Firm location
- Milwaukee, WI, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.