Medical device manufacturer, Laboratoires Anios, has issued a medical device safety alert concerning its OPASTER ANIOS [Article Code: 2504028C6, 2504028HA, 2504028OB, 2504028E2, 2643028BR, 2504028YS, 2504318UE, 2504028UO, 2504028G4, 2504028Z8, 2504028DL, 2504028JC, 25040282Q]
A microbial contamination with Pseudomonas oryzihabitans and Delftia Acidovorans has been identified and localized in the manufacturing process of the affected product, which has resulted in a potential bacterial contamination to the batches produced. The manufacturer has not received any patient incident report to date about the affected product, but, as a precautionary measure, the manufacturer is recalling all batches as they do not comply with the quality expectations.
According to the manufacturer, Pseudomonas oryzihabitans and Delftia Acidovorans are opportunistic environmental bacteria rarely implicated in human infections. They pose little medical risk to healthy people. However, immunocompromised patients are at higher risk of infection.
Corrective actions to eliminate the contamination source are being implemented and the manufacturer has introduced additional hygiene security protocols.
For precautionary reasons, customers are asked to stop, block and isolate immediately using the affected product. Product recall is on-going.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 11 November 2019