FDA-Device2018-03-21Class II
Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
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.
Sold states
US Distribution.
Affected count
21350
Manufactured in
87 Venture Dr, Dover, NH, United States
Products
Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0933-2018Don't want to check this manually?
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