FDA-Device2018-07-04Class II

Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000

Intersurgical Inc
Hazard

When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadvertently cover or block the exhalation port. This could potentially pose a serious health risk to the patient.

Sold states
Distributors in IL, NJ, NV, TX, UT.
Affected count
1340
Manufactured in
6757 Kinne St., E. Syracuse, NY, United States
Products
Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2302-2018

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