Recall Z-0080-2015 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Baxter Healthcare Corp
15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
| Date | Oct 17, 2014 (initiated Oct 17, 2013) |
| Status | Terminated |
| Reason | The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage. |
| Root cause | Component change control |
| Action | Baxter sent an Urgent Product Recall letter dated May 30, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. The recalling firm is instructing their customers to remove all affected products from their facility and quarantine the product subject to the recall. Customers are instructed to return the affected product to Baxter and receive a credit or replacement. For questions contact the Center for One Baxter at 1-800-422-9837. |
| Quantity | 3,085,080 |
| Distribution | Worldwide Distribution - US Nationwide (including Puerto Rico) and countries of, Canada, Australia, New Zealand, Thailand, Malaysia, Singapore, Korea, Japan, Philippines, Columbia, Ecuador, Austria, Bahran, Belgium, Bosnia & Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, G |
| 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 |