Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Re
FDA device recall Z-0985-2024 · posted 2024-02-05 · Open, Classified
Recall details
- Recalling firm
- CooperSurgical, Inc.
- Reason for recall
- Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- GCJ
- Quantity affected
- 127 boxes, 3 kits per box (381 kits total)
- Distribution
- US Nationwide distribution in the state of MO.
- Date initiated
- 2023-08-29
- Date posted
- 2024-02-05
- Location
- Trumbull, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET (K980123) | Louisville Laboratories, Inc. | 1998-03-09 |