ReliaMed Alginate Dressings Recalled for Misplaced Instructions
Advanced Medical Solutions is recalling ReliaMed Alginate/CMC dressings because instructions for use were misplaced in the packaging.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a packaging/labeling error (misplaced IFU) without reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Advanced Medical Solutions Ltd. is recalling 29,204 cartons of ReliaMed Alginate/CMC dressings. The recall was initiated after the company's sole customer discovered that the Instructions For Use (IFU) leaflets were misplaced during a packaging review in January 2015.
The affected products were distributed in Ohio. Each carton contains multiple pouches of dressings and one IFU leaflet. The recall involves specific lot codes identified in the agency's records.
Healthcare providers and consumers should stop using the affected dressings and contact Advanced Medical Solutions for further instructions.
The recalled product
- Product
- ReliaMed¿ 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 Dressing
- Hazard
- Affected units
- 29,204
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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