Recall Z-1194-2017— Argon Medical Devices, Inc

Name: FDA recall Z-1194-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-18

Class II · Terminated

Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2017-01-18, terminated 2017-05-17. It names one FDA 510(k) clearance: K980196. Product: BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens. Reason: The recalling firm received a complaint from one of their customers of a 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: 2017-01-18
Terminated: 2017-05-17
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

BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens

Reason for recall

The recalling firm received a complaint from one of their customers of a 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.