Argon Medical Devices, Inc: Medical Device Recall in 2015 - (Recall #: Z-2188-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.
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

Product Classification:

Class II

Date Initiated: June 18, 2015
Date Posted: July 29, 2015
Recall Number: Z-2188-2015
Event ID: 71533
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.

Status: Terminated
Product Quantity: 6390 units
Code Information:

Lot Numbers: 11088595, 11089104, 11089369, 11089370, 11094673, 11094679, 11095843, 11096115, 11098022, 11098023, 11098643, 11098707

Distribution Pattern:

US

Voluntary or Mandated:

Voluntary: Firm initiated