Argon Medical Devices Recalls Double Male LL Adapter Due to Seal Defect
Argon Medical Devices is recalling Double Male LL Adapters because an incomplete pouch seal may cause a loss of sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (loss of sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Argon Medical Devices, Inc. is recalling its Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The recall involves 49,130 units distributed nationwide, to military/government entities, and to Canada, Australia, the Netherlands, and Spain.
The recall is being conducted because the seal formed on the edge of the pouch may be incomplete. This defect could result in a loss of sterility to the product.
Healthcare facilities and distributors should stop using the affected product and contact Argon Medical Devices for further instructions.
The recalled product
- Product
- Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
- Manufacturer
- Argon Medical Devices, Inc
- Affected units
- 49,130
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)
- Lot number 11229386
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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