# FDA recall Z-0678-2018

> **Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.** · Class II · device recall initiated 2017-07-24.

## Product

Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M

## Reason for recall

Vygon is conducting a voluntary recall of the products and lots listed in this recall, being  initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the  Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging.  This potential lack of adhesive may affect the sterility of the product.

## Distribution

U.S.

## Key facts

- **Recall number:** Z-0678-2018
- **Recalling firm:** Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-24
- **Report date:** 2018-02-28
- **Termination date:** 2019-11-07

- **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-0678-2018

## Citation

> AI Analytics. FDA recall Z-0678-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-0678-2018. Source: US FDA. Licensed CC0.

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