Device product
Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm
Z-0819-2019
Product summary
- Event
- Event 81968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,502 units
- Official record key
device-enforcement:Z-0819-2019
Official wording
Reason: Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
Code information: Model Number UCIN-11-10, Lot Number LFDB
Distribution pattern: Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.
Derived failure modes
-
Unknown
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line