Recall Z-1308-2013 ยท FJL Resectoscope
Karl Storz Endoscopy America Inc
Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
| Date | May 11, 2013 (initiated Jun 1, 2009) |
| Status | Terminated |
| Reason | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. |
| Root cause | Packaging |
| Action | A Safety Alert dated May 29, 2009 was sent to affected customers. The letter informed them of possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products which may result in airborne contamination. Karl Storz requested consignees to inspect their inventory of the subject products thoroughly and look for small holes in the blister trays. Any identified units should be returned to Karl Storz, and a replacement package (6 units per package) will be provided to at no charge. The Karl Storz Customer Support number 1-800-421-0837 ext. 7577 was provided to obtain |
| Quantity | 9432 units |
| Distribution | Distributed Nationwide and in Canada. |
| FDA record | Open on fda.gov |