Recall Z-0474-2012 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter Interlink System Continu-Flo Solution Set with Control-A-Flo Regulator, 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 1C8621 Intended use: for the administration of drug and solutions to patient's vascular sys
| Date | Jan 11, 2012 (initiated Dec 6, 2011) |
| Status | Terminated |
| Reason | During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection. |
| Root cause | Employee error |
| Action | The firm, Baxter, sent an "Urgent Product Recall" letter dated December 6, 2011, via first class mail to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to inspect all locations where their facility's inventory is located for products with the affected lot numbers; return the affected product; request a credit or replacement by calling Baxter Healthcare Center for Service at 1-888-229-0001 between 7:00am to 6:00pm Central time, Monday through Friday; complete and return the attached Customer Reply Form via fax to: 1-847-270-5457, |
| Quantity | 4,272 units |
| Distribution | Worldwide distribution: USA (nationwide) including states of: Alaska, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940867 | CONTROL-A-FLO(TM) REGULATOR Baxter Healthcare Corp, May 5, 1994 |