Recall Z-0288-2020— Argon Medical Devices, Inc

Name: FDA recall Z-0288-2020
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: K810637. Product: (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 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

K810637 — COBE DISPOSABLE PRESSURE TRANSDUCERCobe Laboratories, Inc.·cleared 1981-04-23

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 Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 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.