Argon Medical Devices Recalls Luer Lock Plugs Due to Seal Defect
Argon Medical Devices is recalling specific lots of Luer Lock Plugs because an incomplete seal may cause a loss of sterility.
What this means for you
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, which aligns with the High severity criteria.
Plain-English summary
Argon Medical Devices, Inc. is recalling 49,130 units of Male/Female Luer Lock Plugs (REF 041295000A). The recall affects lot numbers 11228890, 11230669, and 11231874. These sterile, prescription-only medical devices were distributed nationwide, to military/government entities, and to Canada, Australia, the Netherlands, and Spain.
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. No specific injuries or illnesses are reported in the source text.
Healthcare facilities and consumers should stop using the affected plugs and contact Argon Medical Devices for instructions on return or replacement.
The recalled product
- Product
- Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
- Manufacturer
- Argon Medical Devices, Inc
- Category
- Medical Device — Sterile Plugs
- 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 (3)
- Lot numbers 11228890
- 11230669
- and 11231874
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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