Recall Z-1048-05 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter Interlink System Huber Needle Extension Set; a sterile 10'' fluid pathway with an Interlink Y-Injection Site and 3/4'' x 22 gauge needle; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.; product code 2N3709
| Date | Jul 28, 2005 (initiated May 31, 2005) |
| Status | Terminated |
| Reason | Some of the product code 2N3709 extension sets with Y-injections sites were placed in packages labeled as product code 2N3703 extension sets which do not have Y-injection sites. |
| Root cause | Other |
| Action | Baxter sent Urgent Product Recall dated 5/31/05 to their customers on the same date, to the attention of the Director of Materials Management. The accounts were informed of the potential mislabeling, and were requested to check their inventory of any product code labeled 2N3703 or 2N3709 with lot number FC04058. If any of the affected lot is found the accounts were instructed to call Baxter Healthcare Center for Service at 1-888-229-0001 to arrrange for product return and replacement. Any questions were referred to the Center for One Baxter at 1-800-422-9837. |
| Quantity | 4,850 sets |
| Distribution | Arkansas, Florida, Texas, North Carolina, Wisconsin and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961495 | HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE Baxter Healthcare Corp, Jun 26, 1996 |