Device product
Convenience Kit, BREAST HERNIA DYNJ909125G
Z-0447-2026
Product summary
- Event
- Event 97882
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 96,406 total units
- Official record key
device-enforcement:Z-0447-2026
Official wording
Reason: 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.
Code information: DYNJ909125G UDI-DI 40198459130664 (case), 10198459130663 (ea) Lot 25FBU543 25IBD459
Distribution pattern: 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;
Derived failure modes
-
Unknown
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.