Z-2513-2024Class II
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog...
W. L. Gore & Associates, Inc. / initiated 2024-07-03 / Open, Classified / root cause: manufacturing process
W.L. Gore & Associates, Inc. began a recall of GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25 on . FDA classified it as Class II and gives the reason as "Devices were labeled with an expiration date of four years and ten days rather than the validated two years". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2513-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- W. L. Gore & Associates, Inc.
- Product
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
- Product code
- FTL Mesh, Surgical, Polymeric
- Reason for recall
- Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- 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
- Quantity in commerce
- 51 units
- Distribution
- US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.
- Product codes and lots
- Catalog Number: 1BSGC25; UDI-DI: 00733132600755; Lot number: 26590654;
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2513-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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