Argon Medical Devices Recalls AHD Luer Lock Caps Due to Seal Defect
Argon Medical Devices is recalling 49,130 AHD Luer Lock Caps because an incomplete seal may cause 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 is classified as FDA Class II and involves a risk of harm (loss of sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Argon Medical Devices, Inc. is recalling 49,130 units of AHD Luer Lock Caps (REF 501303, Sterile, Rx). The recall involves lot numbers 11228902 and 11230445. The product is a prescription medical device manufactured in Athens, Texas.
The recall was initiated 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. The agency classified this recall as Class II.
Distribution was nationwide, including military and government channels, as well as foreign distribution to Canada, Australia, the Netherlands, and Spain. Users should stop using the affected products and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. 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 numbers 11228902 and 11230445
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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