Recall Z-1162-03 ยท KSB Set, Transfer (Blood/Plasma)
Baxter Healthcare Corp.
Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter and Pressure Pump, 15 drops/mL, 99'', 170 to 260 Micro Filter, Large Standard Blood Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 4C6723; 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 | 272,688 units |
| Distribution | Nationwide, Mexico, Canada, Columbia, Australia, New Zealand and Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993120 | MODIFIED BLOOD RECIPIENT SET Baxter Healthcare Corp, Nov 17, 1999 |