Recall Z-1653-2022 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corporation
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
| Date | Sep 14, 2022 (initiated Aug 9, 2022) |
| Status | Terminated |
| Reason | Firm noted an increase in customer reports of leaks. |
| Root cause | Process design |
| Action | Baxter notified their consignees by letter on 08/09/2022. The letter explained the issue, hazard, and provided the following instructions: "1. If no solution set leaks have been experienced, monitor the use of impacted solution sets closely (including during priming of the administration set and during bedside use) for issues as previously stated. 2. If any solution set leaks are experienced, cease use of the affected product and contact Baxter Corporate Product Surveillance at 800-437-5176 to report the complaint and to arrange for safe return of the product for further investigation. The |
| Quantity | 511,728 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112893 | CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS Baxter Healthcare Corporation, Oct 18, 2011 |