Skip to content
Recall Observatory FDA recall evidence

Device product

Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

Z-0296-2020

October 16, 2018

Class II

Product summary

Firm
Argon Medical Devices, Inc
Event
Event 83633
Status
Terminated
Classification
Class II
Quantity
Total number in recall for all products in dist: 49,130 units
Official record key
device-enforcement:Z-0296-2020

Official wording

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

Code information: Lot numbers 11228902 and 11230445

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    loss of sterility