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
FDA Recall Z-1195-2017 · Posted 2017-02-13
Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeKNW
Date Initiated2017-01-18
Date Terminated2017-05-17
Product Quantity772 boxes
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.
Firm Action
Argon Medical Devices, Inc. is sending an Urgent Product Recall Notice letter dated January 17, 2017, by registered mail to all affected customers. Customers were asked to determine if their inventory shows the package defect and discontinue use of the device and promptly return the affected product. For questions regarding this recall call 903-403-0749.
Root Cause
Equipment maintenance
Distribution Pattern
Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.