PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 29, 2015 Initiated: June 18, 2015 #Z-2188-2015

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.

Details

Units Affected
6390 units
Distribution
US
Location
Athens, TX

Frequently Asked Questions

What product was recalled?
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. Recalled by Argon Medical Devices, Inc. Units affected: 6390 units.
Why was this product recalled?
Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 29, 2015. Severity: Moderate. Recall number: Z-2188-2015.