ClearView Uterine Manipulator with disposable Sound-Dilator (DSD-1000), REF UM210, 7 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123.
FDA Recall Z-1818-2008 · Posted 2008-09-02
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Recalling FirmClinical Innovations, LLC
Recall StatusTerminated
Product CodeLKF
Date Initiated2008-05-12
Date Terminated2008-09-25
Product Quantity500 units
Reason for Recall
Inadequate package seal could compromise sterility.
Firm 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.
Root Cause
Process control
Distribution Pattern
CA, CO, FL, MO, OR, VA. Foreign distribution to Mexico and United Kingdom. No military or government distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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