Z-1306-2013 Class II Terminated
FDA device recall Z-1306-2013 was initiated by Karl Storz Endoscopy America Inc on June 1, 2009 and is designated Class II. Reason for recall: Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. The recall status is terminated (terminated May 13, 2013). Affected quantity: 9432 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2013
- Initiation Date
- June 1, 2009
- Termination Date
- May 13, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9432 units
Product Description
Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Reason for Recall
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
Distribution Pattern
Distributed Nationwide and in Canada.
Code Information
Lot 36785, 36827