Recall Z-0487-2010 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection Y-sites, 3 Luer Activated Valves and Male Luer Lock Adapter with Retractable Collar; 48 individually pouched sterile sets per case; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. A sterile fluid pathway used to administer fluids from a container to a p
| Date | Dec 9, 2009 (initiated Nov 3, 2009) |
| Status | Terminated |
| Reason | The tubing may separate from the distal Clearlink Y-site of the set, which could result in patient injury if the separation occurs during patient use. |
| Root cause | Employee error |
| Action | An "Urgent Product Recall" letter dated November 3, 2009 was sent to the direct accounts via first class mail on the same date, to the attention of the Director of Nursing and the Director of Materials Management. The letter informed the accounts that there have been reports of a separation of the tubing from the distal Clearlink Y-site of the set, with one instance resulting in a serious injury. The accounts were instructed to examine their inventory and remove any sets of Product code 2C8864, Lot number UR09E21238 from inventory and return the affected product for credit or replacement prod |
| Quantity | 173 cases |
| Distribution | Worldwide Distribution -- United States (Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Nevada, New Mexico, Ohio, Tennessee, Texas, Utah and Wisconsin), Canada and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984381 | BURETROL SOLUTION SETS Baxter Healthcare Corp, Feb 19, 1999 |