Z-1094-2016Class II

Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery...

Name: Z-1094-2016 Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery...
Creator: Pro-Dex Inc
Published: 2015-12-23
License: https://open.fda.gov/license/

Pro-Dex Inc / initiated 2015-12-23 / Terminated / root cause: packaging

FDA source

Pro-Dex Inc began a recall of Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver) on 2015-12-23. FDA classified it as Class II and gives the reason as "The sterile battery may contain particulates within the sterile package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1094-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-23
Posted: 2016-03-11
Terminated: 2017-07-21
Recalling firm: Pro-Dex Inc
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).
Product code: MOQ Battery, Replacement, Rechargeable
Reason for recall: The sterile battery may contain particulates within the sterile package.
Root cause tag: packaging
FDA 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 in commerce: 1995 total
Distribution: Distributed in FL.
Product codes and lots: Lots 509567, K055R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1094-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1094-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-11
Z-1095-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-11

Product code MOQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)