Recall Z-1195-2017

Argon Medical Devices, Inc · initiated January 18, 2017

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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

Codes / lots: lots: 11157523, 11158179, 11158180, 11159101, 11159729

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.

FDA-determined cause: Equipment maintenance

Action taken

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.

Details

Recall number
Z-1195-2017
Initiated
January 18, 2017
Posted by FDA
February 13, 2017
Terminated
May 17, 2017
Product code
KNW – Instrument, Biopsy
Quantity
772 boxes
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.
Recalling firm
Argon Medical Devices, Inc, Athens, TX

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1194-2017 Class IIBONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose…The recalling firm received a complaint from one of their customers of a potential defect in the forming of… 01/18/2017Terminated
Z-1196-2017 Class IIHARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow…The recalling firm received a complaint from one of their customers of a potential defect in the forming of… 01/18/2017Terminated