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FDAOctober 3, 2017device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

vygon mfg inc dba churchill medical systemsvygonvygon mfg

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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