The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Pat
Summary
The FDA issued a Class II for The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular pa by Vascutek, Ltd.. Reason: The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees..
Details
Source
Device Recall
External ID
Z-2543-2021
Action Date
2021-10-06
Status
Terminated
Category
device
Product Description
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
Lot/Code Info: To be reported.
Quantity Affected: 159 total vascular grafts and patches
Reason for Recall
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Distribution
Distribution was made to PR and Guam.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-08
Company
Inchinnan, N/A
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 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Vascutek, Ltd. has 4 FDA actions in our database, including 3 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 (Vascutek, Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Vascutek, Ltd. have FDA actions?
Vascutek, Ltd. has 4 FDA actions in our database, including 3 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2543-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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