Z-1195-2017 Class II Terminated

Recalled by Argon Medical Devices, Inc — Athens, TX

Recall Details

Product Type
Devices
Report Date
February 22, 2017
Initiation Date
January 18, 2017
Termination Date
May 17, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
772 boxes

Product Description

T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimens

Reason for Recall

The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.

Distribution Pattern

Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.

Code Information

lots: 11157523, 11158179, 11158180, 11159101, 11159729