Argon Medical Devices, Inc recalls (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx; (2)

Recalled November 13, 2019 · FDA recall Z-0290-2020 · Argon Medical Devices

Hazard

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

Units

Total number in recall for all products in dist: 49,130 units

Sold at

Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.

Description

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

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.

Manufacturer(s)

Argon Medical Devices, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →