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

Recall number

Z-0193-05

Recalling firm

Baxter Healthcare Corp.

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

Status

Terminated

Initiated

2004-04-28

Posted

2004-11-16

Terminated

2007-02-08

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 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.

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.

Lot, serial or model codes

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

510(k) numbers

["K832284","K981792","K984381","K993120","K003225"]

PMA numbers

not on file

Product code

FPA

Firm FEI

1416980

Firm city

Round Lake

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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