One-Piece Introducer Tray kits recalled for sterility failure
Argon Medical Devices is recalling One-Piece Introducer Tray kits containing Lidocaine HCL Injection because they do not meet sterility release criteria. The kits were distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a medical device used in cardiovascular procedures. Failure to meet sterility release criteria on injectable products presents a significant risk of infection, which can result in serious injury or hospitalization, meeting the Severe threshold.
Plain-English summary
Argon Medical Devices, Inc. is recalling One-Piece Introducer Tray kits (REF: 497455 and 497434) that contain Lidocaine HCL Injection USP 1% 10mg/mL in 5mL ampules. These kits were recalled because they do not meet the required release criteria for sterility.
The affected kits were distributed nationwide in the United States, including Puerto Rico, as well as to Trinidad and Tobago internationally. Approximately 200 units are involved in this recall.
Patients and healthcare providers who have received these kits should not use them. Contact Argon Medical Devices, Inc. for instructions on proper handling and replacement of the recalled products.
The recalled product
- Product
- One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
- Manufacturer
- Argon Medical Devices, Inc
- Affected units
- 200
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 (1)
- 497455/20886333214635:00886333214631/11658984 (7/19/2027)
Distribution
Part of a larger recall action
This product is one of 6 recalled by Argon Medical Devices, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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