Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: R
Summary
The FDA issued a Class II for Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantit by CooperSurgical, Inc.. Reason: Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays..
Details
Source
Device Recall
External ID
Z-0985-2024
Action Date
2024-02-14
Status
Ongoing
Category
device
Product Description
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide.
Lot/Code Info: UDI-DI: 60888937027053, lot# 326728.
Quantity Affected: 127 boxes, 3 kits per box (381 kits total)
Reason for Recall
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Distribution
US Nationwide distribution in the state of MO.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-29
Company
Trumbull, CT
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 274 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CooperSurgical, Inc. has 38 FDA actions in our database, including 35 recalls and 3 clearances.
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 (CooperSurgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CooperSurgical, Inc. have FDA actions?
CooperSurgical, Inc. has 38 FDA actions in our database, including 35 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0985-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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