BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens
This recall has been terminated (originally issued February 13, 2017).
- Company
- Argon Medical Devices, Inc
- Recall Initiated
- January 18, 2017
- Posted
- February 13, 2017
- Terminated
- May 17, 2017
- Recall Number
- Z-1194-2017
- Quantity
- 497 boxes
- Firm Location
- Athens, TX
- Official Source
- View on FDA website ↗
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
Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.
Lot / Code Info
lots: 11156986, 11158618, 11158620
Root 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.