Recall Z-0698-2007
Boston Scientific Corporation · initiated February 7, 2007
Product
Boston Scientific SpyGlass Light Cable Reference Number: 4621 UPN M00546210
Codes / lots: Lot Number: 355R
Reason for recall
Light Degradation in transmission-A film may deposit on the front face and limit transmission of light
FDA-determined cause: Other
Action taken
Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.
Details
- Recall number
- Z-0698-2007
- Initiated
- February 7, 2007
- Posted by FDA
- March 31, 2007
- Terminated
- November 15, 2007
- Product code
- EQH – Source, Carrier, Fiberoptic Light
- Quantity
- 13 units
- Distribution
- Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .
- Recalling firm
- Boston Scientific Corporation, Natick, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0696-2007 | Boston Scientific SpyGlass Visualization Probe Reference Number: 4603 UPN M00546030SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe | 02/07/2007Terminated |
| Z-0697-2007 | Boston Scientific SpyGlass Ocular Reference Number: 4604 UPN M00546040SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe | 02/07/2007Terminated |
| Z-0699-2007 | Boston Scientific SpyGlass Camera Ref Number: 4610 UPN M00546100A teal "bloom"/ glare on the subject image during high light conditions. | 02/07/2007Terminated |