Baxter Clearlink Intravenous (IV) Delivery System; the system consists of solution sets, extension sets and blood sets t

FDA device recall Z-0193-05 · posted 2004-11-16 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

FPA

Quantity affected

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

Date initiated

2004-04-28

Date posted

2004-11-16

Date terminated

2007-02-08

Location

Round Lake, IL

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