Recall Z-0513-03 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8527 and 1M8527Y; Baxter Healthcare Corporation, Deerfield, IL 60015
| Date | Feb 6, 2003 (initiated Oct 17, 2002) |
| Status | Terminated |
| Reason | The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter. |
| Root cause | Other |
| Action | Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit. |
| Quantity | 0 |
| Distribution | Nationwide, Australia, Puerto Rico, Brazil, Canada, Sweden, New Zealand, Japan, Mexico, American Samoa, El Salvador, Turkey, Saudi Arabia, Austria, Cayman Islands, Macedonia, Honduras, Kuwait, Hong Kong and Nigeria. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K811078 | RADIATION STERILIZED ADMIN. SET Travenol Laboratories, S.A., Jul 2, 1981 |