Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
This recall has been terminated (originally issued March 11, 2016).
- Company
- Pro-Dex Inc
- Recall Initiated
- December 23, 2015
- Posted
- March 11, 2016
- Terminated
- July 21, 2017
- Recall Number
- Z-1095-2016
- Quantity
- 1995 total
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The sterile battery may contain particulates within the sterile package.
Distribution
Distributed in FL.
Lot / Code Info
Lots 509567, K055R
Root 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.