Food, drugs, devices › Argon Medical Devices, Inc
Device recall: Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Nu
Argon Medical Devices, Inc (Athens, TX) initiated this device recall on 18 Jun 2015; FDA lists 2 product records under event 71533, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 23 Jun 2016. Initiation: voluntary: firm initiated. Argon Medical Devices, Inc has 23 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Argon Medical Devices, Inc, Athens, TX.
Reason for recall
"Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray."
Distribution
"US"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2188-2015 | 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 | 6390 units | Class II | Terminated | 29 Jul 2015 |
| Z-2189-2015 | 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 | 10290 units | Class II | Terminated | 29 Jul 2015 |
Context
Other enforcement events for Argon Medical Devices, Inc
All 23 events for Argon Medical Devices, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 23 Jun 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.