medical Class II Updated 2021-01-06

Intersurgical Inc recalls Smoothbore breathing system with exhalation port 22 mm Devic

Recalled 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.


Hazard / Issue

The device was assembled with the incorrect exhalation port which can cause gas leakage.

Issued by

FDA

Distribution: All of the devices were shipped to the same distributor (McKesson).
Lot/Code Info: Model Number: B0062001 Lot Numbers: 4200283 and 4200286 UDI Codes: (01)00081647202239(10)4200286 (01)00081647202239(10)4200283
View official government recall

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