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Intersurgical Inc recalls Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multi
Recalled January 6, 2021 · FDA recall Z-0753-2021 · Intersurgical
Hazard
The device was assembled with the incorrect exhalation port which can cause gas leakage. · FDA Class II
Units
200 devices
Sold at
All of the devices were shipped to the same distributor (McKesson).
Description
The device was assembled with the incorrect exhalation port which can cause gas leakage.
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.
Manufacturer(s)
Intersurgical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →