FDA-Device2013-07-24Class II
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.
Karl Storz Endoscopy America Inc
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.
Sold states
US distribution to: AZ, FL, IL, IN and TX.
Affected count
40 units
Manufactured in
15 Wells St, N/A, Southbridge, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1728-2013Don't want to check this manually?
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