Recall Z-0648-06 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.8 mL Vol., with 2 injection sites and male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
| Date | Mar 24, 2006 (initiated Dec 15, 2005) |
| Status | Terminated |
| Reason | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Root cause | Other |
| Action | Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include |
| Quantity | 10,704 sets |
| Distribution | Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Australia, Japan, South Korea, Saudi Arabia, India, Mexico, Venezuela, Malaysia, East Timor and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925126 | INTERLINK(TM) INJECTION SITE Baxter Healthcare Corp, Jun 18, 1993 |