Z-1300-06

Boston Scientific Urovac Bladder Evacuator, sterile, single use only; REF/Catalog no. 730-125 and sold...

Name: Z-1300-06 Boston Scientific Urovac Bladder Evacuator, sterile, single use only; REF/Catalog no. 730-125 and sold...
Creator: Boston Scientific Corp
Published: 2006-06-30
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-06-30 / Terminated / root cause: packaging

FDA source

Boston Scientific Corp began a recall of Boston Scientific Urovac Bladder Evacuator, sterile, single use only; REF/Catalog no. 730-125 and sold individually as UPN M0067301250 and in packaged of ten... on 2006-06-30. The reason FDA records is "Sterility is compromised because the product is labeled as sterile, but the packages may have holes in them". 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-1300-06
Status: Terminated
Initiated: 2006-06-30
Posted: 2006-07-27
Terminated: 2008-07-31
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Urovac Bladder Evacuator, sterile, single use only; REF/Catalog no. 730-125 and sold individually as UPN M0067301250 and in packaged of ten as UPN M0067301251.
Product code: KOG
Reason for recall: Sterility is compromised because the product is labeled as sterile, but the packages may have holes in them.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: U.S. accounts were notified via recall letter dated 6/30/06 to cease use of the product and to return it to the firm. International accounts were also notified.
Quantity in commerce: 446,097 units
Distribution: Nationwide and worldwide, including Argentina, Bangladesh, Belgium, Canada, Chile, China, Colombia, Dominican Republic, Egypt, El Salvador, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Portugal, Romania, South Africa, Spain, Sri Lanka, Sweden, Tunisia, Turkey and Venezuela.
Product codes and lots: All lots expiring on or before June 12, 2010.

Product code KOG

K880099Class IIVan-Tec Bladder EvacuatorVan-Tec, Inc. / cleared 1988-03-02

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)