Recall Z-0793-2020— Baxter Healthcare Corporation

Name: FDA recall Z-0793-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-12

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2019-12-12. It names one FDA 510(k) clearance: K961225. 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.. 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..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2019-12-12
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K961225 — CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SETBaxter Healthcare Corp·cleared 1996-06-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.