Z-1728-2013 Class II Terminated
FDA device recall Z-1728-2013 was initiated by Karl Storz Endoscopy America Inc on May 31, 2013 and is designated Class II. 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. The recall status is terminated (terminated July 15, 2013). Affected quantity: 40 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2013
- Initiation Date
- May 31, 2013
- Termination Date
- July 15, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 units
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.
Distribution Pattern
US distribution to: AZ, FL, IL, IN and TX.
Code Information
Lots: 12471, 12281, 12271, 12171, 12101, 12051, 11501, 11401, 09471, 09431, 09251, 09201, 09161, 09091, 09071, 08451.