Arterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
Argon Medical Devices is recalling an Arterial Line Kit containing Lidocaine HCL Injection USP because the kits do not meet sterility release criteria, creating a risk of infection from non-sterile medical injection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which per the rubric requires a severity score of at least 4. Sterility failure in an invasive medical device carries risk of serious infection, meeting the Severe threshold.
Plain-English summary
Argon Medical Devices, Inc is recalling Arterial Line Kit 20ga x 6 (REF: 400115A) containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules. The kits were subject to another recall and were found to not meet release criteria for sterility.
The recall affects 440 units distributed nationwide in the United States, including Puerto Rico, and internationally to Trinidad and Tobago. The affected lot numbers are 11655174, 11655183, 11655185, and 11659131, all with an expiration date of 7/19/2027.
Patients or healthcare providers who have received or are using these kits should stop use immediately and contact their healthcare provider or Argon Medical Devices for instructions on return or replacement. Non-sterile medical devices used in arterial line placement pose a risk of infection.
The recalled product
- Product
- Arterial Line Kit 20ga x 6, REF: 400115A
- Manufacturer
- Argon Medical Devices, Inc
- Hazard
- sterility-failure
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 11655183(7/19/2027)
- 11655185(7/19/2027)
- 11659131(7/19/2027)
Distribution
Distributed nationwide across the United States.
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