FDA-Device2026-07-22Class IPACKAGING DEFECT
Argon Medical Devices Arterial Line Kit recalled for sterility test failure
What this means
Argon Medical Devices is recalling certain Arterial Line Kits (model 20ga x 6, REF: 400115A) that contain Lidocaine HCL Injection. These kits failed sterility testing and do not meet safety release criteria. The affected kits have specific lot numbers with expiration dates in July 2027.
- Check if you have one of the affected lots: 11655174, 11655183, 11655185, or 11659131
- Do not use kits from these lots
- Contact your healthcare provider or Argon Medical Devices for instructions on how to return or dispose of the product
The agency's original wording
Hazard
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Intended for
Adults
Illnesses reported
None reported
Sold states
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Affected count
440
Manufactured in
1445 Flat Creek Rd, Athens, TX, United States
Products
Arterial Line Kit 20ga x 6, REF: 400115A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2708-2026Want us to check the next one for you?
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