Recall Z-0985-2024 ยท GCJ Laparoscope, General & Plastic Surgery
CooperSurgical, Inc.
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.
| Date | Feb 5, 2024 (initiated Aug 29, 2023) |
| Status | Open, Classified |
| Reason | Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays. |
| Root cause | Labeling Change Control |
| Action | An 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 | 127 boxes, 3 kits per box (381 kits total) |
| Distribution | US Nationwide distribution in the state of MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980123 | CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET Louisville Laboratories, Inc., Mar 9, 1998 |