UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Summary
The FDA issued a Class II for UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, non by Uromedica Inc.. Reason: The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Details
Source
Device Recall
External ID
Z-0458-2022
Action Date
2022-01-12
Status
Terminated
Category
device
Product Description
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Lot/Code Info: Lot numbers UM00794 and UM00817, UDI 00180668000106
Quantity Affected: 18 devices
Reason for Recall
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Distribution
US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-22
Company
Plymouth, MN
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 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (Uromedica Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Uromedica Inc. have FDA actions?
This is the only FDA action we have on record for Uromedica Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0458-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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