Recall Z-1095-2016
Pro-Dex Inc · initiated December 23, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
Codes / lots: Lots 509567, K055R
Reason for recall
The sterile battery may contain particulates within the sterile package.
FDA-determined cause: Process change control
Action taken
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.
Details
- Recall number
- Z-1095-2016
- Initiated
- December 23, 2015
- Posted by FDA
- March 11, 2016
- Terminated
- July 21, 2017
- Product code
- MOQ – Battery, Replacement, Rechargeable
- Quantity
- 1995 total
- Distribution
- Distributed in FL.
- Recalling firm
- Pro-Dex Inc, Irvine, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1094-2016 Class II | Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin…The sterile battery may contain particulates within the sterile package. | 12/23/2015Terminated |