Recall Z-1114-2019— Vygon U.S.A.

Name: FDA recall Z-1114-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-06

Class II · Terminated

Class II FDA medical device recall by Vygon U.S.A., initiated 2018-12-06, terminated 2020-05-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.. Reason: DualStop Caps defect causing leaks in affected product.

Recalling firm: Vygon U.S.A.
Classification: Class II
Status: Terminated
Initiated: 2018-12-06
Terminated: 2020-05-12
Firm location: Lansdale, PA, United States

Product description

Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.

Reason for recall

DualStop Caps defect causing leaks in affected product

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