Device product
Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
Z-1094-2016
Product summary
- Firm
- Pro-Dex Inc
- Event
- Event 73034
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1995 total
- Official record key
device-enforcement:Z-1094-2016
Official wording
Reason: The sterile battery may contain particulates within the sterile package.
Code information: Lots 509567, K055R
Distribution pattern: Distributed in FL.
Derived failure modes
-
Foreign material or chemical contamination
particulates