Recall Z-2079-2021 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Cordis Corporation
Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
| Date | Jun 9, 2021 |
| Status | Terminated |
| Reason | The product in the packaging is larger (both inner and outer diameter) than the labeling indicates. |
| Root cause | Under Investigation by firm |
| Action | A letter and Acknowledgement Form sent on June 8, 2021 to each account. Actions requested on your part: 1) Read this Urgent Medical Device Recall letter. 2) Immediately check your inventory to determine if you have any units from the affected lots in your possession. Identify and set aside any units from the identified lots in a manner that ensures that the affected product will not be used. Check all storage and usage locations. 3) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form or email to: GMB-CordisFieldAction@cardinalhe |
| Quantity | 680 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970392 | CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM Cordis Corp., Apr 24, 1997 |