Recall Z-0290-2020— Argon Medical Devices, Inc

Name: FDA recall Z-0290-2020
Creator: U.S. Food and Drug Administration
Published: 2018-10-16

Class II · Terminated

Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2018-10-16, terminated 2021-06-15. It names one FDA 510(k) clearance: K780271. Product: (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx; (2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A, 25/box, Sterile, Rx; (3) Argon Medical Devices Stopcocks, Double 4-Way Stopcock w/Male Luer Lock, REF 041220001A, 25/box, Sterile, Rx; (4) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Rotating Male Luer Lock, REF 041240002A, Sterile, Rx; (5) Argon Medical Devices Stopcocks, North Carolina Baptist Hospital, Winston-Salem, NC, REF 042597300A, 25/box, Sterile, Rx; and (6) Argon Medical Devices 3 Way Stopcock w/Rotating Adapter (1050psi), REF 196590, 25/box, Sterile, Rx. The firm name on the labels is Argon Medical Devices, Inc., Athens, TX.. Reason: The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product..

Recalling firm: Argon Medical Devices, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-10-16
Terminated: 2021-06-15
Firm location: Athens, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K780271 — COBE STOPCOCKCobe Laboratories, Inc.·cleared 1978-03-02

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

(1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx; (2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A, 25/box, Sterile, Rx; (3) Argon Medical Devices Stopcocks, Double 4-Way Stopcock w/Male Luer Lock, REF 041220001A, 25/box, Sterile, Rx; (4) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Rotating Male Luer Lock, REF 041240002A, Sterile, Rx; (5) Argon Medical Devices Stopcocks, North Carolina Baptist Hospital, Winston-Salem, NC, REF 042597300A, 25/box, Sterile, Rx; and (6) Argon Medical Devices 3 Way Stopcock w/Rotating Adapter (1050psi), REF 196590, 25/box, Sterile, Rx. The firm name on the labels is Argon Medical Devices, Inc., Athens, TX.

Reason for recall

The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

Data sourced from openFDA. This site is unofficial and independent of the FDA.