Z-2708-2026Class I

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

Name: Z-2708-2026 Arterial Line Kit 20ga x 6, REF: 400115A
Creator: Argon Medical Devices, Inc
Published: 2026-06-01
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2026-06-01 / Open, Classified / root cause: manufacturing process

FDA source

Argon Medical Devices, Inc began a recall of Arterial Line Kit 20ga x 6, REF: 400115A on 2026-06-01. FDA classified it as Class I and gives the reason as "Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2708-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-06-01
Posted: 2026-07-10
Recalling firm: Argon Medical Devices, Inc
Product: Arterial Line Kit 20ga x 6, REF: 400115A
Product code: GDY Gauze/Sponge, Internal, X-Ray Detectable
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.
Root cause tag: manufacturing process
FDA 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 [email protected]
Quantity in commerce: 440
Distribution: Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Product codes and lots: 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);

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2708-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2704-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2705-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2706-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2707-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2708-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2709-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10

Product code GDY

K780871Class IArterial Line KitArgon Medical Corp. / cleared 1978-06-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)