FDA-Device2015-07-29Class II

T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304

Argon Medical Devices, Inc
Hazard

Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.

Sold states
US
Affected count
10290 units
Manufactured in
1445 Flat Creek Rd, N/A, Athens, TX, United States
Products
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2189-2015

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