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Recall Observatory FDA recall evidence

Device product

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

Z-2302-2018

April 25, 2018

Class II

Product summary

Firm
Intersurgical Inc
Event
Event 80250
Status
Terminated
Classification
Class II
Quantity
1340
Official record key
device-enforcement:Z-2302-2018

Official wording

Reason: 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.

Code information: 0261604, 0671602, 0671603, 0741609, 0751601 , 0821605, 0821606, 0891605, 0891606, 0951609, 0961601, 1751601 , 0011802, 0011803, 0021803, 0081808 and 0161805.

Distribution pattern: Distributors in IL, NJ, NV, TX, UT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.