LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number: 61049252 Exp. Date: 2016-06
- 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:
- Mislabeled with an incorrect expiration date
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252
Product Codes/Lot Numbers:
Lot Number: 61049252 Exp. Date: 2016-06
Distribution:
Distributed in: CA, CO, KS, MN, UT, WA, WI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1294-2015
Related Recalls
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
LeMaitre Vascular
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.
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.