Device product
Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
Z-0753-2021
Product summary
- Event
- Event 86800
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 devices
- Official record key
device-enforcement:Z-0753-2021
Official wording
Reason: The device was assembled with the incorrect exhalation port which can cause gas leakage.
Code information: Model Number: B0062001 Lot Numbers: 4200283 and 4200286 UDI Codes: (01)00081647202239(10)4200286 (01)00081647202239(10)4200283
Distribution pattern: All of the devices were shipped to the same distributor (McKesson).
Derived failure modes
-
Unknown
The device was assembled with the incorrect exhalation port which can cause gas leakage.