FDA Device recall Z-2188-2015
Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501
- FDA Device
- Class II
- terminated
- Published 2015-07-29
On 2015-07-29 the FDA classified a Class II recall of Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501 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-2188-2015 |
| 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
Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601
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: 11088595, 11089104, 11089369, 11089370, 11094673, 11094679, 11095843, 11096115, 11098022, 11098023, 11098643, 11098707 |
|---|
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-2188-2015%22
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