Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
Reason for recall: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. Distribution: International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI; Quantity: 96,406 total units Lot/code info: HIP PINNING DYNJ909308D UDI-DI 40198459055288 (case), 10198459055287 (ea) Lots 25FBB311 25GBC282 25GBW486; ORTHO SPINE ST CLAIR DYNJ901048N UDI-DI 40198459055554 (case), 10198459055553 (ea) Lots 25GBQ070; SET UP DYNJ909132F UDI-DI 40198459130572 (case), 10198459130571 (ea) Lots 25GBI845 25IBF708; UROLOGY MINOR DYNJ909123F UDI-DI 40198459130602 (case), 10198459130601 (ea) Lots 25GBT826 25IBF707
40198459055288, 10198459055287, 40198459055554, 10198459055553, 40198459130572, 10198459130571, 40198459130602, 10198459130601
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.