FDA-Device2021-01-06Class II
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.
Intersurgical Inc
Hazard
The device was assembled with the incorrect exhalation port which can cause gas leakage.
Sold states
All of the devices were shipped to the same distributor (McKesson).
Affected count
200 devices
Manufactured in
6757 Kinne St, N/A, East Syracuse, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0753-2021Don't want to check this manually?
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