ReliaMed Silver Alginate Dressing Recalled for Missing Instructions
Advanced Medical Solutions is recalling ReliaMed Silver Alginate dressings because some cartons are missing the required Instructions For Use leaflet.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation/packaging issue (missing IFU leaflet) with no reported injuries or illnesses, fitting the 'Low' severity criteria for packaging-only problems.
Plain-English summary
Advanced Medical Solutions Ltd. is recalling 47,569 cartons of ReliaMed Silver Alginate/CMC dressings. The recall was initiated after the company's sole customer discovered during a warehouse review that some cartons were missing the required Instructions For Use (IFU) leaflet.
The affected products are distributed in Ohio. The recall covers specific lot numbers identified by the manufacturer. The issue is a packaging defect where the IFU leaflet, which is required to be included in each carton, was misplaced or omitted.
Consumers and healthcare facilities should check their inventory for the affected lot numbers. If the IFU leaflet is missing from a carton, the product should be returned to the supplier or the manufacturer for replacement or credit. No adverse health consequences are expected from the missing documentation, but the instructions are necessary for proper use of the medical device.
The recalled product
- Product
- ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.
- Manufacturer
- Advanced Medical Solutions Ltd.
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 47,569
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Advanced Medical Solutions Ltd. 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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