Recall Z-2302-2018 ยท CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
Intersurgical Inc
Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
| Date | Apr 25, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | On April 25, 2018, the firm issued an Urgent Medical Device Recall letter to its distributors. Customers were advised of the product issue and recall. Recall Instructions: 1. Immediately discontinue use and quarantine any stock with the product number B0062000 described above in this recall notification. 2. If you have distributed any of this product, please immediately contact your customers, advise them of the recall situation and have them return their outstanding recalled stock to you. 3. Contact Intersurgical Customer Support at 800-828-9633 for a Return Goods Authorization Number (RGA). |
| Quantity | 1340 |
| Distribution | Distributors in IL, NJ, NV, TX, UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.