Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/GTIN: 20643169738717 Lot Number 60068186
- 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:
- Medtronic Vascular
- Reason for Recall:
- Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has all the correct labeling, and all the other information and configuration details on both the carton and the pouch are correct.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Product Codes/Lot Numbers:
UDI/GTIN: 20643169738717 Lot Number 60068186
Distribution:
Distributed in: CA, IA, NE, TN, TX, VA, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3253-2018
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