Recall Z-2189-2015— Argon Medical Devices, Inc

Name: FDA recall Z-2189-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-18

Class II · Terminated

Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2015-06-18, terminated 2016-06-23. It names one FDA 510(k) clearance: K980196. Product: 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. 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

510(k) clearances named in this recall

1 on FDA's record

K980196 — MD TECH BIOPSY SET FOR BONE AND BONE MARROWMedical Device Technologies, Inc.·cleared 1998-02-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.