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.
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation is recalling Clearlink System Continu-Flo Administration Sets with product codes 2C8519, 2C8537, and 2C8541. These sets, used to administer fluids from a container into a patient, have male Luer bodies that fall at the lower end of and within ISO specifications for outer diameter. This design requires a higher than expected connection force to fully insert and securely tighten the Luer to the ONE-LINK connector. Approximately 271 million units have been distributed worldwide, including throughout the United States and in Bermuda, the Bahamas, Trinidad and Tobago, Grand Cayman, St. Thomas, Guyana, Barbados, Mexico, Canada, and New Zealand. All lots of these three product codes are affected.
The source does not specify a remedy for consumers who have these products.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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. Quantity: 271,014,984 units Lot/code info: Product Codes: 2C8519, UDI 00085412048994; 2C8537, UDI 00085412048970; and 2C8541, UDI 00085412071107 All Lots
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.