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U.S. Department of Health and Human Services

Class 2 Device Recall Regard, CarterThomason CloseSure System

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 Class 2 Device Recall Regard, CarterThomason CloseSure Systemsee related information
Date Initiated by FirmAugust 29, 2023
Date PostedFebruary 05, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0985-2024
Recall Event ID 93822
510(K)NumberK980123 
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
ProductBox 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.
Code Information UDI-DI: 60888937027053, lot# 326728.
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact
203-601-5200 Ext. 3300
Manufacturer Reason
for Recall		Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
FDA Determined
Cause 2		Labeling Change Control
ActionAn Urgent Medical Device Field Safety Notice dated August 29, 2023 was sent to the one distributor receiving shipments of the affected product lot. Customers are advised to complete the acknowledgement form, Affected product is to be returned to CooperSugical for credit. Contact CooperSurgical at +1-203-601-5200 extension 3300 during normal operating hours of 09:00 - 17:00 M-F EST, email Recall@coopersurgical.com.
Quantity in Commerce127 boxes, 3 kits per box (381 kits total)
DistributionUS Nationwide distribution in the state of MO.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GCJ
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