ProductGuru
AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

[Recalled] 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 f

recall fda device united-states

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductNavigator 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.
Brand / manufacturerBoston Scientific Corporation
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0442-2014
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date05 November 2013
EAN / barcode15579545

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Boston Scientific Corporation

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

Shop Recalled Navigator l3F 15F
Search on Amazon ›Find on eBay ›
As an Amazon Associate and eBay Partner, we may earn from qualifying purchases.

Explore by topic

Looking up a product? Use ProductGuru — free barcode & product database with 35M+ products. Search by EAN / UPC barcode.
Was this page helpful?