Recall Z-0193-05 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter Clearlink Intravenous (IV) Delivery System; the system consists of solution sets, extension sets and blood sets that have a luer activated valve for IV access, which allows the administration of medications/solutions with a needleless luer syringe; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
| Date | Nov 16, 2004 (initiated Apr 28, 2004) |
| Status | Terminated |
| Reason | Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the Clearlink needleless device. |
| Root cause | Other |
| Action | An Urgent Device Correction letter and reply form dated 4/28/04 were sent to all U.S. Clearlink customers, informing them of the reports of increased infection rates abd describing the revision of the product labeling with additional statements that relate to product usage and reinforcement of standard clinical practices and proper aseptic technique. The revised labeling statements are as follows: * Ensure clamp is open. Swab Luer activated surface with preferred antiseptic prior to first use and before every subsequent connection. * Don not swab Luer activated surface when clamp is closed o |
| Quantity | 29,425,708 sets |
| Distribution | Nationwide, and internationally through Baxter subsidiaries to Macedonia, Nigeria, Saudi Arabia, South Africa, Ireland, Italy, Denmark, Germany, the Netherlands, Hong Kong, Indonesia, Singapore, Spain, Belgium, Norway, United Kingdom, France and Luxembourg. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003225 | SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE Baxter Healthcare Corp, Oct 19, 2000 |
| K832284 | SOLUTION ADMIN. SET 2C9096 W/10 PVC Travenol Laboratories, S.A., Dec 29, 1983 |
| K981792 | SOLUTION ADMINISTRATION SET Baxter Healthcare Corp, Aug 17, 1998 |
| K984381 | BURETROL SOLUTION SETS Baxter Healthcare Corp, Feb 19, 1999 |
| K993120 | MODIFIED BLOOD RECIPIENT SET Baxter Healthcare Corp, Nov 17, 1999 |