Device product
"J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Z-0814-2019
Product summary
- Event
- Event 81968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,900 units
- Official record key
device-enforcement:Z-0814-2019
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 IMKBMN-11R-10-X, Lot Numbers LJUE, LEAC, LFKX; Model Number IMKBMN-11R-10, Lot Numbers LK0J, LEHU
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