Recall Z-1305-2013— Karl Storz Endoscopy America Inc
Class II · Terminated
Class II FDA medical device recall by Karl Storz Endoscopy America Inc, initiated 2009-06-01, terminated 2013-05-13. It names 2 FDA 510(k) clearances: K983569, K934647. Product: Electrode, cutting, 24FR (27050G/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..
- Recalling firm
- Karl Storz Endoscopy America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2009-06-01
- Terminated
- 2013-05-13
- Firm location
- El Segundo, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K983569 — KSEA MONOPOLAR VAPORIZATION ELECTRODES
- K934647 — KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Electrode, cutting, 24FR (27050G/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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.