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: DYNJ909116D UDI-DI 40198459055356 (case), 10198459055355 (ea) Lots 25FBM604 25GBP604; DYNJ909124F UDI-DI 40198459130619 (case), 10198459130618 (ea) Lots 25FBB831 25GBI833
40198459055356, 10198459055355, 40198459130619, 10198459130618
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.