Recall Z-0943-05 ยท FMG Stopcock, I.V. Set
Baxter Healthcare Corp.
Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension Set, 10 drops/mL, product code 3C0062s; a sterile, nonpyrogenic fluid pathway for administration of IV fluids; Manufactured by an affiliate of Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in Costa Rica
| Date | Jun 30, 2005 (initiated Apr 21, 2005) |
| Status | Terminated |
| Reason | There is an unsecure connection between the male Luer and the stopcock on the I.V. extension set. |
| Root cause | Other |
| Action | Recall letters dated 4/21/05 were sent to the direct accounts via first class mail on the same date to the attention of the Director of Materials Management. The accounts were informed of the reports of an unsecure connection between the male luer and the stopcock due to silicone on the male luer tip, and were 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. |
| Quantity | 107,832 sets |
| Distribution | Nationwide and internationally to American Samoa and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022895 | ELCAM STOPCOCKS AND MANIFOLDS Medical Device Consultants, Inc., Oct 18, 2002 |