Recall Z-1387-2018 ยท KDN System, Perfusion, Kidney
Preservation Solutions, Inc.
Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002. Intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and transplantation into a recipient.
| Date | Feb 26, 2018 |
| Status | Terminated |
| Reason | Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag.. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent: Product Recall Notification letters, dated February 26, 2018, were sent to consignees. The instructions include, halting distribution of any 2 Liter bags in inventory; and, arranging for the return of affected units. Preservation Solutions, Inc. provided a notification letter for their consignees to provide to their customers. The letter instructed customers to return any 2 Liter bags to their supplier, and to complete and return the acknowledgement form. |
| Quantity | 31,104 units |
| Distribution | Worldwide Distribution -- USA and Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073693 | COSTORSOL Preservation Solutions, Inc., Jul 3, 2008 |