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Open, Classified

KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.

FDA Recall Z-1391-2023 · Posted 2023-04-14

Recalling FirmPro-Dex Inc
Recall StatusOpen, Classified
Product CodeGET
Date Initiated2023-02-14
Product Quantity199 devices

Reason for Recall

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

Firm Action

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 [email protected]

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

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

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