ClearView Uterine Manipulator with disposable Sound-Dilator (DSD-1000), REF UM210, 7 cm, Sterile, Clinical Innovations,
FDA device recall Z-1818-2008 · posted 2008-09-02 · Terminated
Recall details
- Recalling firm
- Clinical Innovations, LLC
- Reason for recall
- Inadequate package seal could compromise sterility.
- Action taken
- 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
- Status
- Terminated
- Product code
- LKF
- Quantity affected
- 500 units
- Distribution
- CA, CO, FL, MO, OR, VA. Foreign distribution to Mexico and United Kingdom. No military or government distribution.
- Date initiated
- 2008-05-12
- Date posted
- 2008-09-02
- Date terminated
- 2008-09-25
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLEARVIEW UTERINE MANIPULATOR (K940681) | Clinical Innovations, Inc. | 1994-07-26 |