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Recall Observatory FDA recall evidence

Device product

Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a container into the patients vascular system through a vascular access device.

Z-0793-2020

December 12, 2019

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 84511
Status
Ongoing
Classification
Class II
Quantity
271,014,984 units
Official record key
device-enforcement:Z-0793-2020

Official wording

Reason: Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.

Code information: Product Codes: 2C8519, UDI 00085412048994; 2C8537, UDI 00085412048970; and 2C8541, UDI 00085412071107 All Lots

Distribution pattern: Worldwide distribution - US Nationwide distribution and countries of Bermuda, Bahamas, Trinidad and Tobago, Grand Cayman, St. Thomas, Guyana and Barbados, Mexico, Canada, and New Zealand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.