Device product
Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm
Z-0817-2019
Product summary
- Event
- Event 81968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 units
- Official record key
device-enforcement:Z-0817-2019
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 BMNJ-MEC-1110, Lot Number LHT1
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