Recall Z-1818-2008 ยท LKF Cannula, Manipulator/Injector, Uterine
Clinical Innovations, LLC
ClearView Uterine Manipulator with disposable Sound-Dilator (DSD-1000), REF UM210, 7 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123.
| Date | Sep 2, 2008 (initiated May 12, 2008) |
| Status | Terminated |
| Reason | Inadequate package seal could compromise sterility. |
| 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 | 500 units |
| Distribution | CA, CO, FL, MO, OR, VA. Foreign distribution to Mexico and United Kingdom. No military or government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940681 | CLEARVIEW UTERINE MANIPULATOR Clinical Innovations, Inc., Jul 26, 1994 |