Recall Z-2302-2018— Intersurgical Inc
Class II · Terminated
Class II FDA medical device recall by Intersurgical Inc, initiated 2018-04-25, terminated 2019-04-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000. 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..
- Recalling firm
- Intersurgical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-25
- Terminated
- 2019-04-09
- Firm location
- E. Syracuse, NY, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.