FDA Enforcement
Class II
Terminated
Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Recall: Z-1310-2013
·
Reported May 22, 2013
Enforcement
- Recall Number
- Z-1310-2013
- Event ID
- 55358
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Karl Storz Endoscopy America Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 22, 2013
- Initiation Date
- June 1, 2009
- Classification Date
- May 11, 2013
- Termination Date
- May 13, 2013
- Address
- 2151 East Grand Avenue, El Segundo, CA, 90245, United States
Description
Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Reason
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
Code Info
Lot 36850
Distribution
Distributed Nationwide and in Canada.
Quantity
9432 units