Device 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.
Z-1728-2013
Product summary
- Event
- Event 65505
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 units
- Official record key
device-enforcement:Z-1728-2013
Official wording
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.
Code information: Lots: 12471, 12281, 12271, 12171, 12101, 12051, 11501, 11401, 09471, 09431, 09251, 09201, 09161, 09091, 09071, 08451.
Distribution pattern: US distribution to: AZ, FL, IL, IN and TX.
Derived failure modes
-
Sterility assurance
packaging may be compromised, and therefore the sterility