Recall Z-2795-2011 ยท MSB System And Accessories, Isolated Heart, Transport And Preservation
Vitrolife, Inc.
XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex used for perfusion of donor lungs. Perfadex with THAM kits, 8 x 1000mL REF 19017, and 2 x 2800mL REF 19018.
| Date | Jul 12, 2011 (initiated May 12, 2011) |
| Status | Terminated |
| Reason | Precipitation observed in some bottles of Tham buffer used for adjusting pH of Perfadex prior to perfusion of donor lungs. |
| Root cause | Process control |
| Action | XVIVO Perfusion, part of the Vitrolife Group, sent out a "Partial recall of Perfadex with THAM" letter on May 13, 2011 to all affected customers. Customers were instructed to to quarantine all Perfadex with THAM. Replacement THAM was to be shipped by Vitrilife within a few days and the exchanged THAM was to immediately sent to Vitrolife, Englewood, CO. For additional Information please call (303) 762-1933 |
| Quantity | 1457 bottles |
| Distribution | Worldwide distribution including USA and Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081997 | PERFADEX WITH THAM Vitrolife Sweden AB, Oct 9, 2008 |