Argon Medical Devices, Inc recalls (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 pack

Recalled November 13, 2019 · FDA recall Z-0293-2020 · 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 Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300, 2 clamps per package, 5 packages/ shelf box, 10 shelf boxes/case (for a total of 50/2-clamp packages/case), Sterile, Rx; (3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, REF 046-1-301, 2 clamps per package, 6 packages/box, 50 boxes/case, Sterile, Rx; and (4) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Large Angled, REF 046-1-401, 2 clamps per package, 5 packages/box, 50 boxes/case. The firm name on the label 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 →