Argon Medical Devices Recalls Sterile Adapters Due to Seal Defects
Argon Medical Devices is recalling specific lots of sterile double female and male luer lock adapters because incomplete pouch seals may compromise 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, fitting the High severity criteria.
Plain-English summary
Argon Medical Devices, Inc. is recalling specific lots of Double Female LL Adapters and Double Male LL Adapters. These sterile, prescription-only medical devices are used to convert male fittings to female luer locks or female fittings to male luer locks. The recall involves 49,130 units 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 product pouch may be incomplete. This defect could result in a loss of sterility to the product. The affected lot numbers for the Double Female LL Adapter are 11228606, 11227966, and 11226655. The affected lot numbers for the Double Male LL Adapter are 11227508, 11229885, 11230268, and 11231393.
Healthcare facilities and consumers should check their inventory for these specific lot numbers. If the products are found, they should be removed from use and returned to the distributor or manufacturer according to the recall instructions.
The recalled product
- Product
- (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 25/bo
- Manufacturer
- Argon Medical Devices, Inc
- Hazard
- 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 (5)
- 11227966
- 11226655
- 11229885
- 11230268
- and 11231393.
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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