Product was released for distribution to 63 consignees nationwide. The recall was appropriately extended to the consumer/user level; i.e., the physicians and hospitals who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
Description du dispositif
Rita Brand Habib 4X Electrosurgical Coagulator, || Catalog Number: 4401US; || Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Reference Pad - Pak and Pediatric - Pak, lots A1785 up to A1805 and P433 up to P445 respectively, distributed from || May 15, 2014 with new equipment or as a substitute for || consumables
Description du dispositif
It is used to perform electric shocks in cases of cardio-respiratory arrest and fibrillation.