Recall Z-1095-2016 ยท MOQ Battery, Replacement, Rechargeable
Pro-Dex Inc
Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
| Date | Mar 11, 2016 (initiated Dec 23, 2015) |
| Status | Terminated |
| Reason | The sterile battery may contain particulates within the sterile package. |
| Root cause | Process change control |
| Action | A customer notification letter was sent 12/23/15. The letter instructs the customer to cease distribution and use of the recalled lots. It also recommends that the inventory and distribution records be evaluated immediately to ensure that affected product is removed from any potential point of use. Return product to: Returns Department (Recall complaint ClS-001) Pro-Dex, Inc 2361 McGaw Avenue Irvine, California 92614 USA Reference the Recall Complaint # on the outside of the shipping box. If any questions or concerns, please contact the QARA group at Pro-Dex at 949 769 3200. |
| Quantity | 1995 total |
| Distribution | Distributed in FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.