FDA Device recall Z-2189-2015
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL
- FDA Device
- Class II
- terminated
- Published 2015-07-29
On 2015-07-29 the FDA classified a Class II recall of T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL by Argon Medical Devices, citing potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2189-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-18 |
| Published | 2015-07-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Argon Medical Devices |
| Distribution | n/a |
Product
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
Reason
Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
Identifiers
| code_info | Lot Numbers: 11088295, 11088596, 11088597, 11089105, 11089366, 11094182, 11094681, 11094912, 11095381, 11095844, 110958…Lot Numbers: 11088295, 11088596, 11088597, 11089105, 11089366, 11094182, 11094681, 11094912, 11095381, 11095844, 11095845, 11095951, 11096558, 11097278, 11097504, 11098024, 11098647, 11099173 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2189-2015%22
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