Recall Z-1173-03 ยท KSB Set, Transfer (Blood/Plasma)
Baxter Healthcare Corp.
Fenwal Blood Component Recipient Set with Standard Blood Filter, 10 drops/mL, 55'', 170 to 260 Micron Filter, catalog 4C2100; 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 | 133,008 units |
| Distribution | Nationwide, Mexico, Canada, Columbia, Australia, New Zealand and Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K881321 | BLOOD/SOLUTION SET W/PRESSURE PUMP Baxter Healthcare Corp, Jun 16, 1988 |