RecallRadar

FDA Device recall Z-0288-2020

(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile…

On 2019-11-13 the FDA classified a Class II recall of (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile… by Argon Medical Devices, citing the seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0288-2020
ClassificationClass II
Statusterminated
Initiated2018-10-16
Published2019-11-13
Last updated2026-09-13 11:55 UTC
CompanyArgon Medical Devices
DistributionUS

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.

Reason

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

Identifiers

code_info
(1) Double Female LL Adapter-special adapter to convert male fitting to a female luer lock - Lot numbers 11228606, 1122…(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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0288-2020%22

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