(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.
This recall has been terminated (originally issued October 16, 2018).
- Company
- Argon Medical Devices, Inc
- Recall Initiated
- October 16, 2018
- Terminated
- June 15, 2021
- Recall Number
- Z-0293-2020
- Quantity
- Total number in recall for all products in dist: 49,130 units
- Firm Location
- Athens, TX
- Official Source
- View on FDA website ↗
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.
Distribution
Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
Lot / Code Info
(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200 - Lot number 11230432; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300 - Lot numbers 11226690 and 11231581 (3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, REF 046-1-301 - Lot number 11227669; (4) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Large Angled, REF 046-1-401 - Lot numbers 11228371 and 11230677.
Root Cause
Equipment maintenance
Action Taken
The recalling firm began issuing letters dated 10/16/2018 on 10/16/2018 via registered mail identifying the issue and the action to be taken by the customer.