Recall Z-0194-2016 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Baxter Healthcare Corp.
Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
| Date | Oct 6, 2015 |
| Status | Terminated |
| Reason | Leakage from the inlet port of the 15L Cycler Drainage Bags. |
| Root cause | Under Investigation by firm |
| Action | Baxter sent an Urgent Product Recall letter dated October 8, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recalling firm will ask customers to locate and separate all affected products, contact the recalling firm to arrange for a return, and complete the customer reply form. Further questions, please call (800) 422-9837. |
| Quantity | 19,440 units |
| Distribution | US Distribution and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K791899 | CYCLER SETS MOD. #5C4143, 5C4144, 5C4145 Travenol Laboratories, S.A., Nov 13, 1979 |