Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 2013040058
- 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:
- Boston Scientific Corporation
- Reason for Recall:
- The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Product Codes/Lot Numbers:
2013040058
Distribution:
Distributed in: TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1164-2014
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