Argon Medical Devices, Inc: Arterial Line Kit 20ga x 6, REF: 400115A

Recall number

Z-2708-2026

Recalling firm

Argon Medical Devices, Inc

Product

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

Status

Open, Classified

Initiated

2026-06-01

Posted

2026-07-10

Terminated

not on file

Reason

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

Root cause

Material/Component Contamination

Action

On 6/1/2026, correction notices were sent to customers who were asked to do the following: 1) Do not use the affected Lidocaine vials included in affected Kits and Sets in scope of this notice 2) Review your inventory for any product covered by this Medical Device Notification. If any items from the affected lot are identified: - Place a copy of this notice with the affected product - Apply the enclosed stickers to the packaging (kit) to clearly identify the item and remind users to discard affected lidocaine. 3) At the point of use, upon opening the kit, discard the affected Lidocaine vials in accordance with your facility's procedures. 4) Obtain Lidocaine separately through your facility pharmacy and prepare / administer it per institutional protocols prior to the procedure. 5) Complete and return the response form via email Arbee.cummings@argonmedical.com

Quantity

440

Distribution

Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.

Lot, serial or model codes

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);

510(k) numbers

["K780871"]

PMA numbers

not on file

Product code

GDY

Firm FEI

1625425

Firm city

Athens

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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