The Food and Drug Administration classified 13 separate recall records on August 31, covering Medline convenience kits distributed nationwide, and the products involved include the prep trays used for cesarean sections and vaginal deliveries. The FDA record for the cesarean prep tray lists 222,653 units in commerce for the recall event.
The defect is not in the tray. It is in one component inside it. Each affected kit contains a BD ChloraPrep Clear 1 mL applicator, the single-use swab used to disinfect skin immediately before a needle, incision, or catheter goes in. Some of those applicator pouches may carry what the FDA record describes as an open or incomplete seal.
