LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number: SLC3672¿SLC3663 SLC3663¿SLC3667¿
- 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:
- Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
Product Codes/Lot Numbers:
Lot Number: SLC3672¿SLC3663 SLC3663¿SLC3667¿
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0386-2016
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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.