Recall Z-0449-03 ยท KSB Set, Transfer (Blood/Plasma)
Baxter Healthcare Corp.
Y-Type Blood/Solution Set, catalog #1C8117; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 88'' long, 10 drops per mL; Baxter Healthcare Corporation, Deerfield, IL 60015
| Date | Jan 16, 2003 (initiated Dec 18, 2002) |
| Status | Terminated |
| Reason | Leakage may occur at the inlet port |
| Root cause | Other |
| Action | The affected product codes and lot numbers were recalled by letter dated 12/18/02. The customers were informed of the potential leakage at the inlet port, and were requested to inspect their inventory for the affected products and destroy those found. The accounts were requested to complete the enclosed reply form and certificate of destruction and return them to Baxter for credit issuance. |
| Quantity | 3,792 sets |
| Distribution | Nationwide |
| 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 |