Boston Scientific SpyGlass Visualization Probe Reference Number: 4603 UPN M00546030
This recall has been terminated (originally issued March 31, 2007).
- Company
- Boston Scientific Corporation
- Recall Initiated
- February 7, 2007
- Posted
- March 31, 2007
- Terminated
- November 15, 2007
- Recall Number
- Z-0696-2007
- Quantity
- 115 units
- Firm Location
- Natick, MA
- Official Source
- View on FDA website ↗
Reason for Recall
SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe
Distribution
Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .
Lot / Code Info
Lot number: 527301, 527302, 533202, 625401, 628902, 630001, 633201, 635501, 702901
Root Cause
Other
Action Taken
Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.