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

FDA Recall #Z-1114-2019 — Class II — December 6, 2018

Recall #Z-1114-2019 Date: December 6, 2018 Classification: Class II Status: Terminated

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

Recalling Firm

Vygon U.S.A. — Lansdale, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

339,800

Distribution

US Nationwide distribution.

Code Information

Lot codes: 310518FD 050618FD 140318FD 160617FD 200917FD 061117FD 090118FD 200218FD 290318FD 110418FD

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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