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Recall

Class II — Argon Medical Devices, Inc

Recalling firmARGON MEDICAL DEVICES, INC
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThe seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
ProductArgon 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.
QuantityTotal number in recall for all products in dist: 49,130 units
DistributionDistribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
Initiated2018-10-16
Classified2019-11-05
Terminated2021-06-15
Recall numberZ-0292-2020
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Argon Medical Devices, Inc (Z-0292-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83633/

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