Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
FDA device recall Z-1307-2013 · posted 2013-05-11 · Terminated
Recall details
- Recalling firm
- Karl Storz Endoscopy America Inc
- Reason for recall
- Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- FJL
- Quantity affected
- 9432 units
- Distribution
- Distributed Nationwide and in Canada.
- Date initiated
- 2009-06-01
- Date posted
- 2013-05-11
- Date terminated
- 2013-05-13
- Location
- El Segundo, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KSEA MONOPOLAR VAPORIZATION ELECTRODES (K983569) | KARL STORZ Endoscopy-America, Inc. | 1999-01-08 |
| KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION (K934647) | KARL STORZ Endoscopy-America, Inc. | 1994-02-09 |