Recall Z-0427-2011 ยท KDN System, Perfusion, Kidney
Preservation Solutions Inc
Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage of kidney, liver and pancreas organs. Manufactured by: Preservation Solutions, Inc., Elkhorn, WI 53121. Manufactured for: BTL Solutions LLC, a subsidiary of Bridge to Life, Ltd., 1225 Laurel Street, Columbia, SC 29201.
| Date | Nov 22, 2010 (initiated Sep 24, 2010) |
| Status | Terminated |
| Reason | Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter. |
| Root cause | Labeling mix-ups |
| Action | Bridge to Life, Ltd, issued a Notification of Product Recall letter dated October 18, 2010 to all direct accounts identifying the affected product and labeling issue. Customers were informed that all product from the affected lot has been replaced by the firm. Customers with questions about this recall can contact Bridge to Life at 803 673-4548.. |
| Quantity | 55 units |
| Distribution | Nationwide Distribution - in US to the states of CA, MO, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073693 | COSTORSOL Preservation Solutions, Inc., Jul 3, 2008 |