Recall Z-2589-2021 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Atrium Medical Corporation
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
| Date | Aug 25, 2021 |
| Status | Terminated |
| Reason | The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling. |
| Root cause | Under Investigation by firm |
| Action | On August 25, 2021, the firm issued Urgent Medical Device - Removal letters to affected customers. Customers were instructed to do the following: - Please examine your inventory immediately to determine if you have any of the Atrium Advanta VXT Vascular Grafts with Part Number/REF Number 22059. - If you have affected product with Part Number/REF Number 22059, please remove the affected products from areas of use and return the product(s) to Getinge following the instructions in the letter. - Should you have affected product you are eligible for either a replacement or credit. - Please for |
| Quantity | 28 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of Florida and the countries of South Korea and Poland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992960 | ADVANTA GRAFT (>6MM) Atrium Medical Corp., Oct 1, 1999 |