Recall Z-2837-2011 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use nonpyrogenic fluid pathway; 200 sets per case; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 2N3375 Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access dev
| Date | Jul 15, 2011 (initiated Jul 6, 2011) |
| Status | Terminated |
| Reason | Some of the individual extension set packages were improperly sealed, compromising the sterility of the product. |
| Root cause | Packaging |
| Action | The firm, Baxter, sent an "Urgent Product Recall" letter dated July 6, 2011 via first class mail to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to locate and remove all affected product from their facility; call Baxter Healthcare's Center for Service at 1-888-229-0001 between 7:00 am and 6:00 pm Central Time, Monday through Friday to return affected product and receive credit; complete and return the attached CUSTOMER REPLY FORM to Baxter via fax at 1-847-270-5457 or scan and email to fca@baxter.com and if you are a dealer, w |
| Quantity | 9,800 sets |
| Distribution | Worldwide distribution: USA (nationwide) including: AL, LA, MO, SD, TX and WV; and country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925126 | INTERLINK(TM) INJECTION SITE Baxter Healthcare Corp, Jun 18, 1993 |