FDA recall Z-2302-2018

Intersurgical Inc · Class II · device

Product

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

Reason for recall

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.

Distribution

Distributors in IL, NJ, NV, TX, UT.

Key facts

Status
Terminated
Initiation date
2018-04-25
Report date
2018-07-04
Termination date
2019-04-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
E. Syracuse, NY, United States

Primary source

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