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GORE SEAMGUARD Bioabsorbable Staple Line Reinforce recallZ-2513-2024 · W.L. Gore & Associates, Inc. · initiated Jul 3, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from W.L. Gore & Associates, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Devices were labeled with an expiration date of four years and ten days rather than the validated two years.

FDA root cause category: Process control

What the company is doing

On July 1, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken by the customer/user: 1. Identify and return any unused devices within the scope of this recall for replacement. 2. Please complete and sign the enclosed CUSTOMER RESPONSE FORM and return to [email protected] within 2 weeks of receipt of this notification. 3. This notice needs to be shared with those who should be aware within your institution or to any organization where potentially affected devices have been transferred (as appropriate). 4. If a listed device has been used, there is no patient follow-up needed and no further actions required other than informing Gore the device was used. Please indicate the used device(s) on the CUSTOMER RESPONSE FORM and return to [email protected]. In the event that an adverse event occurs: Any adverse event involving the GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers should be reported to W. L. Gore & Associates and the country specific regulatory authorities immediately. To report an event to W. L. Gore & Associates, email: [email protected] or contact: USA: 800 528 1866 Ext. 44922 / 928 864 4922, Fax 928 864 4364 Healthcare professionals and consumers may report adverse events or quality problems directly to FDA using the FDA MedWatch Website: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm As a reminder, there is no known additional risk to patients who have been treated with a GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers that is subject to this voluntary recall. We regret any confusion or inconvenience this matter may cause. Please be assured that Gore is committed to ensuring top product quality and customer satisfaction and will be implementing actions as appropriate. Please contact your local Gore Field Sales Associate with any questions regarding this notice, and to coordinate the return and replacement

Recall details

Recall number
Z-2513-2024
Status
Open, Classified
Initiated by the company
Jul 3, 2024
Posted by the FDA
Aug 6, 2024
Recalling firm
W.L. Gore & Associates, Inc.
Quantity
51 units
Product code
FTL
FDA submissions
K053200
Distribution
US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.

Product description

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;

Code information (models, lots, serial numbers)

Catalog Number: 1BSGC25; UDI-DI: 00733132600755; Lot number: 26590654;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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