Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergen…

Recall date

October 3, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0933-2018

FDA classification

Class II

Brand / firm

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

Sold / distributed

US Distribution.

Why it was recalled

The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.