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Recall Observatory FDA recall evidence

Device 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.

Z-1728-2013

May 31, 2013

Class II

Product summary

Firm
Karl Storz Endoscopy America Inc
Event
Event 65505
Status
Terminated
Classification
Class II
Quantity
40 units
Official record key
device-enforcement:Z-1728-2013

Official wording

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 information: Lots: 12471, 12281, 12271, 12171, 12101, 12051, 11501, 11401, 09471, 09431, 09251, 09201, 09161, 09091, 09071, 08451.

Distribution pattern: US distribution to: AZ, FL, IL, IN and TX.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    packaging may be compromised, and therefore the sterility