Recall Z-1153-03 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Continu-Flo Solution Set, 10 drops/mL, 104'', 0.22 Micron Downstream High Pressure Extended Life Filter, 3 Injection Sites, Male Luer Lock Adapter, catalog 2C6593; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
| Date | Aug 21, 2003 (initiated Jul 16, 2003) |
| Status | Terminated |
| Reason | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| Root cause | Other |
| Action | Recalled by letter dated 7/16/03. The accounts were informed of the potential for leaks in the set tubing, and asked to inspect their inventory for the affected product codes and lots, segregate any affected products found and discard them according to local procedures. The customers will receive credit for the discarded affected product. |
| Quantity | 4,727 units |
| Distribution | Nationwide, Mexico, Canada, Columbia, Australia, New Zealand and Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964850 | SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER Baxter Healthcare Corp, Feb 25, 1997 |