Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/box, Sterile, Rx. 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-0292-2020
- 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
Lot numbers 11228890, 11230669, and 11231874
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.
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