Recall Z-0519-03 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter Microbore 3-Lead Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3342; Baxter Healthcare Corporation, Deerfield, IL 60015; 50 units per case
| 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 | 130,040 units |
| 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 |