Recall Z-0293-2020— Argon Medical Devices, Inc

Name: FDA recall Z-0293-2020
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: K771701. 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.. 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

K771701 — VESSEL-CLUDEMed General·cleared 1977-12-13

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 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.

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.