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Z-2708-2026Class I

Argon Medical Devices, Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Argon Medical Devices, Inc
Product type
Device
Status
Ongoing
Report date
2026-07-22
Distribution
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Firm state
TX
Product quantity
440
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Product description

Arterial Line Kit 20ga x 6, REF: 400115A

Code / lot info

REF/UDI-DI Box:Unit/Lot(Expiration): 400115A/20886333212884:00886333212880/11655174(7/19/2027), 11655183(7/19/2027), 11655185(7/19/2027), 11659131(7/19/2027);

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →