The FDA classified a recall on August 31 covering the Medline Ultrasound Breast Pack, a pre-assembled sterile convenience kit named for use in ultrasound-guided breast procedures. One lot totaling 300 kits, distributed nationwide, is affected according to the FDA recall record, which lists the product under the plastic surgery and accessories kit category.
The number is small. The patient population is not incidental. Ultrasound-guided breast procedures often sit between an abnormal imaging finding and a diagnosis, which means the people in these rooms can include patients awaiting a cancer diagnosis and patients already in cancer treatment.
