Medical device manufacturer, Lohmann & Rauscher GmbH & Co. KG, has issued a medical device safety alert concerning its Gauze compresses with x-ray contrast thread in Kitpack and SetPack [Material: 15110; Lot: 19183A09II].
The manufacturer informed of the precautionary product recall of gauze compresses with RK thread due to a possible breaking or fraying of the RK thread used. Based on feedback from three clinics, it became known that under tension the x-ray contrast threads in the affected gauze compresses can break and fray at individual points.
Theoretically, small pieces of thread could occur when the x-ray thread breaks or frays. This could, for example, lead to inflammation and/or granuloma formation when remaining in the body.
Affected users should return the products to the manufacturer and product recall is on-going.
According to the manufacturer, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 August 2020