Recall Z-0845-05 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutions with a needleless luer syringe; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
| Date | May 17, 2005 (initiated Feb 28, 2005) |
| Status | Terminated |
| Reason | Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve. |
| Root cause | Other |
| Action | Recall letters dated 2/28/05 were sent to the direct accounts via first class mail on the same date to the attention of the Director of Nursing. The accounts were informed of the increase in reports of ClearLink valve occlusion, requested to examine their inventory for the affected lots of product, and call Baxter Healthcare Center for Service at 1-888-229-001 to return the affected product for credit. The letters included a copy of the Technical Letter revised 5/4/04, outlining the correct preparation and use ClearLink valve product, including detecting valve re-knits. |
| Quantity | 1,171,116 sets |
| Distribution | Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Panama, Australia, New Zealand and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003225 | SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE Baxter Healthcare Corp, Oct 19, 2000 |
| K791496 | LOW PLASTICIZER ADMINISTRATION SETS Travenol Laboratories, S.A., Apr 8, 1980 |
| K961225 | CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET Baxter Healthcare Corp, Jun 21, 1996 |
| K962581 | STOPCOCK MANIFOLD GANGS Baxter Healthcare Corp, Aug 28, 1996 |
| K984381 | BURETROL SOLUTION SETS Baxter Healthcare Corp, Feb 19, 1999 |