—#32974

Product

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

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K003225, K832284, K981792, K984381, K993120
Affected lot / code info: all lots of product code 2N8399, 1C8678, 1C8680, 1C8683, 1C8684, 1C8687, 1C8693, 1C8702, 1C8704, 1C8705, 1C8706, 1C8707, 1C8712, 1C8722, 1C8723, 1C8727, 2C0168, 2C6254, 2C6255, 2C6256, 2C7461, 2C7462, 2C8401, 2C8402, 2C8419, 2C8425, 2C8428, 2C8515, 2C8519, 2C8537, 2C8541, 2C8546, 2C8548, 2C8571, 2C8593, 2C8606, 2C8607, 2C8610, 2C8612, 2C8632, 2C8634, 2C8671, 2C8700, 2C8720, 2C8750, 2C8751, 2C8819, 2C8851, 2C8857, 2C8858, 2C8860, 2C8862, 2C8864, 2C8865, 2C8875, 2C8891, 2C8895, 2C8920, 2C8921, 2C8930, 2C8931, 2H7462, 2H7463, 2H8401, 2H8480, 2H8486, 2H8519, 2H8603, 2H8720, 2H8750, 2H8819, 2H8860, 2H8862, 2H8864, 2H8865, 2N8300, 2N8334, 2N8335, 2N8341, 2N8371, 2N8373, 2N8374, 2N8377, 2N8378, 2N9204K, 2N9205K, 3C0122, 3C0134, 3C0139, 3C0143, 3C0148, 3C0150, 3C0151, 3C0157, 3C0158, 3C0159, 3C0160, 3C0162, 3C0165, 4C8714, 4C8723, 4H8723

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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 or valve is recessed. Ineffective swabbibg may result. Replace if valve remains recessed. * Flush Luer activated valve after blood infusion/sampling. If valve cannot be cleared of blood, replace immediately. * Luer lock vacutainer holders, syringes and accessories are recommended for blood sampling. If blood remains on valve surface after sampling, swab surface. * If intermittently disconnecting set from Luer activated valve, immediately cover male Luer with a sterile replacement protector.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2004-04-28
Posted by FDA: 2004-11-16
Terminated: 2007-02-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #32974. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.