FDA recall Z-0753-2021

Intersurgical Inc · Class II · 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.

Reason for recall

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

Distribution

All of the devices were shipped to the same distributor (McKesson).

Key facts

Status
Terminated
Initiation date
2020-11-11
Report date
2021-01-06
Termination date
2022-08-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Syracuse, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0753-2021