Recall Z-1728-2013— Karl Storz Endoscopy America Inc
Class II · Terminated
Class II FDA medical device recall by Karl Storz Endoscopy America Inc, initiated 2013-05-31, terminated 2013-07-15. FDA's recall record names no specific 510(k) clearance for this event. Product: 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions.. Reason: Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected..
- Recalling firm
- Karl Storz Endoscopy America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-31
- Terminated
- 2013-07-15
- Firm location
- Southbridge, MA, United States
Product description
27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions.
Reason for recall
Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected.
Data sourced from openFDA. This site is unofficial and independent of the FDA.