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Karl Storz Endoscopy America Inc recalls 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated f
Recalled July 24, 2013 · FDA recall Z-1728-2013 · Karl Storz Endoscopy America
Hazard
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 Class II
Units
40 units
Sold at
US distribution to: AZ, FL, IL, IN and TX.
Description
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.
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.
Manufacturer(s)
Karl Storz Endoscopy America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →