FDA-Device2013-12-11Class II
Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, 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.
Boston Scientific Corporation
Hazard
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.
Sold states
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Ireland, Denmark, Italy, France, Canada, Great Britain, Switzerland, South Africa, Germany, and the Netherlands.
Affected count
274
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0440-2014Don't want to check this manually?
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