Argon Medical Devices Septishield II Recalled for Potential Sterility Loss
Argon Medical Devices is recalling Septishield II products because an incomplete 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, meeting the criteria for a High severity score.
Plain-English summary
Argon Medical Devices, Inc. is recalling Septishield II products (80 cm, REF 497302) 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 recall includes 49,130 units distributed nationwide, including military and government channels. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain. The affected lot numbers are 11228251 and 11229805.
Healthcare providers and consumers should stop using the affected products and contact Argon Medical Devices for further instructions.
The recalled product
- Product
- Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
- 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 (1)
- Lot numbers 11228251 and 11229805
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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