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Baxter Clearlink Intravenous (IV) Delivery System recallZ-0193-05 · Baxter Healthcare Corp. · initiated Apr 28, 2004

Terminated All recalls posted in November 2004

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0193-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 28, 2004
Posted by the FDA
Nov 16, 2004
Recalling firm
Baxter Healthcare Corp.
Quantity
29,425,708 sets
Product code
FPA
FDA submissions
K832284, K981792, K984381, K993120, K003225
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.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Other devices under the same FDA submission

15 devices cleared under K832284, K981792, K984381, K993120, K003225 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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