Reported Jul 4, 2018 · Terminated
Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
Intersurgical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intersurgical Inc · 6757 Kinne St. · E. Syracuse, NY · 13057
Is this the product you have?
- Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
- Lot codes and dates
0261604067160206716030741609075160108216050821606089160508916060951609096160117516010011802001180300218030081808 and 0161805
- Amount recalled
- 1340
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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