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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 emer
Recalled March 21, 2018 · FDA recall Z-0933-2018 · Vygon MFG, Inc., dba/ Churchill Medical Systems
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. · FDA Class II
Units
21350
Sold at
US Distribution.
Description
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.
Product
Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
Manufacturer(s)
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →