# FDA recall Z-0933-2018

> **Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.** · Class II · device recall initiated 2017-10-03.

## 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

- **Recall number:** Z-0933-2018
- **Recalling firm:** Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0933-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0933-2018. Source: US FDA. Licensed CC0.

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