KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g.

FDA device recall Z-1391-2023 · posted 2023-04-14 · Open, Classified

Recall details

Recalling firm

Pro-Dex Inc

Reason for recall

Incorrect Unique Device Identifier/GTIN code was used on product.

Action taken

On or about 11/08/2022, the firm contacted its customer to inform them that the Unique Device Identifier (UDI/GTIN) code was incorrectly utilized for the the Pro-Dex E-Coupling Adapter Assembly. Customers are instructed to: Immediately cease distribution and us of the affected products. Inventory and distribution records should be evaluated immediately to ensure that affected Return the affected products to Returns Department (Recall CAPA-22-015) Pro-Dex, Inc. 2361 McGaw Avenue Irvine, California 92614 USA Reference the "Recall CAPA-22-015" on the outside of the shipping box For questions or concerns, contact the QARA group at Pro-Dex at 949-769-3200 or email Angel.Domingo@Pro-Dex.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GET

Quantity affected

199 devices

Distribution

U.S. Nationwide distribution in the state of FL.

Date initiated

2023-02-14

Date posted

2023-04-14

Location

Irvine, CA