Karl Storz Endoscopy America Inc: Medical Device Recall in 2013 - (Recall #: Z-1728-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 31, 2013

Date Posted: July 24, 2013

Recall Number: Z-1728-2013

Event ID: 65505

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.

Status: Terminated

Product Quantity: 40 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated