Recall Z-1174-2016 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Cordis Corporation
CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.
| Date | Mar 15, 2016 (initiated Dec 31, 2015) |
| Status | Terminated |
| Reason | Incorrect cannula of the sheath introducer (smaller than intended). |
| Root cause | Mixed-up of materials/components |
| Action | The firm, Cordis, sent an 'Urgent MEDICAL DEVICE CORRECTION (Field Safety Notice) dated 12/31/2015 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Read the Description of the problem section carefully to fully understand the issue involved. 2) Check your inventory to determine if you have any remaining affected product in your possession. Check all storage and usage locations. The purpose is to identify the product, not to remove the product. 3) Keep a copy of this notice with any affected product. 4) Re |
| Quantity | 1,985 units |
| Distribution | US Nationwide Distribution including states of:AL, AZ, CA, CO, CT, FL, GA, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ,NY, OH, OR, PA, RI, TN, TX, VA, WA, WV, and Hawaii. |
| 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 |