Z-1728-2013Class II

27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is...

Name: Z-1728-2013 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is...
Creator: Karl Storz Endoscopy America Inc
Published: 2013-05-31
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2013-05-31 / Terminated / root cause: packaging

FDA source

Karl Storz Endoscopy America Inc began a recall of 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... on 2013-05-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1728-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-31
Posted: 2013-07-13
Terminated: 2013-07-15
Recalling firm: Karl Storz Endoscopy-America, Inc.
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.
Product code: GBA Catheter, Balloon Type
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: 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.
Quantity in commerce: 40 units
Distribution: US distribution to: AZ, FL, IL, IN and TX.
Product codes and lots: Lots: 12471, 12281, 12271, 12171, 12101, 12051, 11501, 11401, 09471, 09431, 09251, 09201, 09161, 09091, 09071, 08451.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1728-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1728-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-12

Product code GBA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)