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.
Reported: January 15, 2020 Initiated: December 12, 2019 #Z-0793-2020
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 271,014,984 units
- Distribution
- 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.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Baxter Healthcare Corporation. Units affected: 271,014,984 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 15, 2020. Severity: Moderate. Recall number: Z-0793-2020.
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