Recall Z-1222-2011 ยท FZT Cutter, Surgical
Maquet Cardiovascular
Maquet HEARTSTRING Aortic Cutter 4.3 mm, AC-3043, Lot numbers 9081071 and 9082071, Manufactured by Maquet Cardiovascular, Wayne, New Jersey. Intended for use by cardiac surgeons during CABG procedures to create an opening in the wall of a vessel.
| Date | Feb 11, 2011 (initiated Jun 4, 2010) |
| Status | Terminated |
| Reason | Pouch integrity may be compromised, resulting in loss of sterility. |
| Root cause | Process control |
| Action | Urgent Device Removal letters were sent out on June 10, 2020 by Federal Express. The letter identified the affected product, described the reason for the recall, and asked for all affected product to be returned. The firm asked customers to examine their inventory and to discontinue distributing the affected lots. In addition, customers are to complete and return the Field Action Response form. If the affected product was further distributed, those customers also need to be notified of the recall and return their affected product to their distributor. All affected returned products may be |
| Quantity | 395 units |
| Distribution | Worldwide Distribution -- USA, including states of IA, KY, IL, WI, TX and NC and countries of Japan, Germany and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.