Recall Z-1086-05 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter Sabraset 6060 Administration Set with Pre-attached 250 mL Bag and Cassette, product code 560500-250; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Mexico
| Date | Aug 6, 2005 (initiated May 4, 2005) |
| Status | Terminated |
| Reason | The inlet and outlet lines of the administration set may be reversed, which would result in reverse flow. |
| Root cause | Other |
| Action | Baxter sent Urgent Device Correction letters dated 5/4/05 to their customers, to the attention of the Director of Nursing, via first class mail on the same date. The accounts were informed of the one complaint of reverse assembly of the administration set, and were provided with diagrams showing the configuration of a correct assembly and an incorrect assembly of the sets. The accounts were instructed to inspect the sets carefully before use to assure correct assembly. The accounts were requested to destroy any misassembled sets found and complete the certificate of destruction enclosed wit |
| Quantity | 7,516 sets |
| Distribution | Nationwide and internationally to Australia, Belgium, Canada and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002679 | 6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351 Baxter Healthcare Corp, Sep 18, 2000 |