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Recall Observatory FDA recall evidence

Device product

(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 25/box, Sterile, Rx. The firm name on the labels is Argon Medical Devices, Inc., Athens, TX.

Z-0288-2020

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-0288-2020

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: (1) Double Female LL Adapter-special adapter to convert male fitting to a female luer lock - Lot numbers 11228606, 11227966, 11226655; and (2) Double Male LL Adapter-special adapter to convert a female fitting to a male luer lock - Lot numbers 11227508, 11229885, 11230268, and 11231393.

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