Recall Z-2188-2015— Argon Medical Devices, Inc
Class II · Terminated
Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2015-06-18, terminated 2016-06-23. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Argon Medical Devices, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-18
- Terminated
- 2016-06-23
- Firm location
- Athens, TX, United States
Product description
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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.