Recall Z-1728-2013
Karl Storz Endoscopy America Inc · initiated May 31, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lots: 12471, 12281, 12271, 12171, 12101, 12051, 11501, 11401, 09471, 09431, 09251, 09201, 09161, 09091, 09071, 08451.
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.
FDA-determined cause: Packaging
Action taken
The firm, Karl Storz, sent a "A SAFETY ALERT-ATTENTION NEEDED" letter dated May 31, 2013 to all customers who purchased the 27023WU Balloon Catheter. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory and to return the recalled product back to Karl Storz.. The customers were also instructed to complete and fax back the Recall Response Form attached with the safety alert letter at Fax #424-218-8559. If you have any questions, please feel free to call 424-218-8289.
Details
- Recall number
- Z-1728-2013
- Initiated
- May 31, 2013
- Posted by FDA
- July 13, 2013
- Terminated
- July 15, 2013
- Product code
- GBA – Catheter, Balloon Type
- Quantity
- 40 units
- Distribution
- US distribution to: AZ, FL, IL, IN and TX.
- Recalling firm
- Karl Storz Endoscopy America Inc, Southbridge, MA