Z-1817-2008

ClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator (DSD-1000), REF CV2000, 9 cm...

Name: Z-1817-2008 ClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator (DSD-1000), REF CV2000, 9 cm...
Creator: Clinical Innovations, LLC
Published: 2008-05-12
License: https://open.fda.gov/license/

Clinical Innovations, LLC / initiated 2008-05-12 / Terminated / root cause: manufacturing process

FDA source

Clinical Innovations, LLC began a recall of ClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator (DSD-1000), REF CV2000, 9 cm, Sterile, Clinical Innovations, 747 West 4170 South... on 2008-05-12. The reason FDA records is "Inadequate package seal could compromise sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1817-2008
Status: Terminated
Initiated: 2008-05-12
Posted: 2008-09-02
Terminated: 2008-09-25
Recalling firm: Clinical Innovations, LLC
Product: ClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator (DSD-1000), REF CV2000, 9 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123.
Product code: LKF Cannula, Manipulator/Injector, Uterine
Reason for recall: Inadequate package seal could compromise sterility.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified by letter on 05/12/2008 with instructions to conduct the recall to the end user. All remaining product is to be quarantined and returned to CI. A response form was included and a letter template to use in any sub-recall. Contact Richard Dixon at 801-268-8200 if you have questions.
Quantity in commerce: 260 units
Distribution: CA, CO, FL, MO, OR, VA. Foreign distribution to Mexico and United Kingdom. No military or government distribution.
Product codes and lots: Lot Number 080154

Product code LKF

K940681Class IIClearview Uterine ManipulatorClinical Innovations, Inc. / cleared 1994-07-26

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)