Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UPN M0062502290, Catalog 250-229, 15579545, 15579546, 15615465, 15630771, 15630772, 15688533, 15688534, 15813601, 15823202, 15880464, 15927981, 16159896, 16175942, 16196763, 16373048,
- 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 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
Product Codes/Lot Numbers:
UPN M0062502290, Catalog 250-229, 15579545, 15579546, 15615465, 15630771, 15630772, 15688533, 15688534, 15813601, 15823202, 15880464, 15927981, 16159896, 16175942, 16196763, 16373048,
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0442-2014
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