Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set recall
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…
Why was Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UPN M0062502270, Catalog 250-227, Lot 15708431, 15708432, 15708433, 15812875, 15836355, 15855545, 15876213 , 15896950, 15935564, 16028474, 16044445, and 16046280
- Product
- 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…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 274
- Distribution
- 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.
- Recall date
- December 11, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)