Argon Medical Devices, Inc: Arterial Line Kit 20ga x 6, REF: 400115A
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Argon Medical Devices, Inc
- Product
- Arterial Line Kit 20ga x 6, REF: 400115A
- Reason / 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.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- Recall initiated
- 2026-06-01
- Code 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);
- Product quantity
- 440
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Athens
- State
- TX
- Country
- United States
- Event id
- 99069
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