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Terminated

Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

FDA Recall Z-1095-2016 · Posted 2016-03-11

Recalling FirmPro-Dex Inc
Recall StatusTerminated
Product CodeMOQ
Date Initiated2015-12-23
Date Terminated2017-07-21
Product Quantity1995 total

Reason for Recall

The sterile battery may contain particulates within the sterile package.

Firm 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.

Root Cause

Process change control

Distribution Pattern

Distributed in FL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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