Recall Z-1306-2013
Karl Storz Endoscopy America Inc · initiated June 1, 2009
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Codes / lots: Lot 36785, 36827
Reason for recall
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
FDA-determined cause: Packaging
Action taken
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 a Return Authorization Number (RMA) and arrange replacement. Questions and comments were forwarded to Technical Support at 1-800-421-0837 ext. 5350.
Details
- Recall number
- Z-1306-2013
- Initiated
- June 1, 2009
- Posted by FDA
- May 11, 2013
- Terminated
- May 13, 2013
- Product code
- FJL – Resectoscope
- Quantity
- 9432 units
- Distribution
- Distributed Nationwide and in Canada.
- Recalling firm
- Karl Storz Endoscopy America Inc, El Segundo, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1305-2013 Class II | Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | 06/01/2009Terminated |
| Z-1307-2013 Class II | Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | 06/01/2009Terminated |
| Z-1308-2013 Class II | Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | 06/01/2009Terminated |
| Z-1309-2013 Class II | Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | 06/01/2009Terminated |
| Z-1310-2013 Class II | Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | 06/01/2009Terminated |
| Z-1311-2013 Class II | Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie.…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | 06/01/2009Terminated |
| Z-1312-2013 Class II | Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | 06/01/2009Terminated |
| Z-1313-2013 Class II | Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | 06/01/2009Terminated |
| Z-1314-2013 Class II | Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | 06/01/2009Terminated |
| Z-1315-2013 Class II | Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie.…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | 06/01/2009Terminated |
| Z-1316-2013 Class II | Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | 06/01/2009Terminated |