FDA recall Z-0933-2018

Product

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

Reason for recall

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.

Distribution

US Distribution.

Key facts

Status

Terminated

Initiation date

2017-10-03

Report date

2018-03-21

Termination date

2020-01-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dover, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0933-2018