Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve s
Summary
The FDA issued a Class II for Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 E by Diversatek Healthcare. 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 polyb.
Details
Source
Device Recall
External ID
Z-1771-2022
Action Date
2022-09-28
Status
Terminated
Category
device
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.
Lot/Code Info: UDI/DI 00816734021361, lot number 001919, 2024-10-31, shipped between 9-27-2021 and 10-22-2021.
Quantity Affected: 245 devices
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-29
Company
Milwaukee, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 145 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Diversatek Healthcare has 8 FDA actions in our database, including 7 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Diversatek Healthcare) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Diversatek Healthcare have FDA actions?
Diversatek Healthcare has 8 FDA actions in our database, including 7 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1771-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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