Z-2302-2018 Class II Terminated
FDA device recall Z-2302-2018 was initiated by Intersurgical Inc on April 25, 2018 and is designated Class II. 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 … The recall status is terminated (terminated April 9, 2019). Affected quantity: 1340.
Recall Details
- Product Type
- Devices
- Report Date
- July 4, 2018
- Initiation Date
- April 25, 2018
- Termination Date
- April 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1340
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.
Distribution Pattern
Distributors in IL, NJ, NV, TX, UT.
Code Information
0261604, 0671602, 0671603, 0741609, 0751601 , 0821605, 0821606, 0891605, 0891606, 0951609, 0961601, 1751601 , 0011802, 0011803, 0021803, 0081808 and 0161805.