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

FDA device recall Z-1094-2016 · posted 2016-03-11 · Terminated

Recall details

Recalling firm

Pro-Dex Inc

Reason for recall

The sterile battery may contain particulates within the sterile package.

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.

Root cause

Process change control

Status

Terminated

Product code

MOQ

Quantity affected

1995 total

Distribution

Distributed in FL.

Date initiated

2015-12-23

Date posted

2016-03-11

Date terminated

2017-07-21

Location

Irvine, CA