Recall Z-1776-2018 ยท PEH Hemodialysis Catheter Luer End Cap
Transonic Systems Inc
Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.
| Date | Feb 15, 2018 |
| Status | Terminated |
| Reason | The sterility of the device cannot be assured. There is a potential for an increased risk of infection. |
| Root cause | Process control |
| Action | The recalling firm has sent all of its customers a Recall Notification Letter dated February 15, 2018, and has included a Customer Reponse Form that requests that customers either return or destroy the ADT1018 Tubing in their possession. For further questions, please call (800) 353-3569. |
| Quantity | 6044 |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution and to the states of : NJ, NY, OH, PA, and TX., and to the countries of : Canada, South Korea, Thailand, Australia and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021571 | TRANSONIC FLOW-QC SET MODEL ADT1010 Transonic Systems, Inc., Aug 12, 2002 |