LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: LSG1130, exp. 2017-04; LSG1132, exp. 2017-11
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- LeMaitre Vascular, Inc.
- Reason for Recall:
- Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
Product Codes/Lot Numbers:
LSG1130, exp. 2017-04; LSG1132, exp. 2017-11
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1054-2013
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The device was incorrectly packed in the wrong size labeled outer packaging.
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.