FDA Enforcement
Class II
Terminated
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.
Recall: Z-1728-2013
·
Reported July 24, 2013
Enforcement
- Recall Number
- Z-1728-2013
- Event ID
- 65505
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Karl Storz Endoscopy America Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 24, 2013
- Initiation Date
- May 31, 2013
- Classification Date
- July 12, 2013
- Termination Date
- July 15, 2013
- Address
- 15 Wells St, N/A, Southbridge, MA, 01550-4503, United States
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
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 Info
Lots: 12471, 12281, 12271, 12171, 12101, 12051, 11501, 11401, 09471, 09431, 09251, 09201, 09161, 09091, 09071, 08451.
Distribution
US distribution to: AZ, FL, IL, IN and TX.
Quantity
40 units