CooperSurgical, Inc.: Carter-Thomason CloseSure System XL Recalled for Incorrect Component Labels

Agency Publication Date: February 5, 2024

Summary

CooperSurgical, Inc. is recalling 381 units of the Carter-Thomason CloseSure System XL due to a labeling error where the "Contents" section on the individual tray lids incorrectly describes the components inside. This recall affects 127 boxes, each containing 3 kits, specifically from lot number 326728. Because the labeling does not match the actual instruments provided, medical professionals may be misinformed about the tools available during surgical procedures. You should contact your healthcare provider or the manufacturer to ensure you have the correct information and components.

Risk

Incorrect component descriptions on surgical kit packaging can lead to confusion or the use of improper instruments during a procedure. This may cause surgical delays or complications if the medical team relies on the inaccurate labeling for preparation or use.

What You Should Do

Check your medical supplies for the Carter-Thomason CloseSure System XL, REF 733776, packaged in boxes of 3 kits.
Verify if your product belongs to lot number 326728 with UDI-DI 60888937027053.
Inspect the Tyvek lid of individual kit trays to see if the 'Contents' section matches the physical components (one Suture Passer, one 5 mm Pilot Guide, and one 10/12 mm Pilot Guide).
If you identify an affected kit, contact CooperSurgical, Inc. at their Trumbull, CT location by calling 1-800-243-2974 for instructions on how to handle the mislabeled products.
Contact your healthcare provider or hospital administrator if you have questions regarding the use of these devices in past or future procedures.
For further information or to report concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact manufacturer for instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Carter-Thomason CloseSure System XL (Box of 3 Systems)

Model / REF:

REF 733776

UPC Codes:

60888937027053

Lot Numbers:

326728

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93822

Status: Active

Manufacturer: CooperSurgical, Inc.

Manufactured In: United States

Units Affected: 127 boxes, 3 kits per box (381 kits total)

Distributed To: Missouri

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medical supplies for the Carter-Thomason CloseSure System XL, REF 733776, packaged in boxes of 3 kits.

Verify if your product belongs to lot number 326728 with UDI-DI 60888937027053.

Inspect the Tyvek lid of individual kit trays to see if the 'Contents' section matches the physical components (one Suture Passer, one 5 mm Pilot Guide, and one 10/12 mm Pilot Guide).

If you identify an affected kit, contact CooperSurgical, Inc. at their Trumbull, CT location by calling 1-800-243-2974 for instructions on how to handle the mislabeled products.

Contact your healthcare provider or hospital administrator if you have questions regarding the use of these devices in past or future procedures.

For further information or to report concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.