# FDA recall Z-1634-2018

> **Vygon U.S.A.** · Class II · device recall initiated 2018-02-28.

## Product

Neonatal PICC Tray, Product Code: AMS-8010CP-1    Convenience kit for the insertion of PICCs into the vascular system.

## Reason for recall

Potential friction holes may affect the sterility of the product.

## Distribution

Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.

## Key facts

- **Recall number:** Z-1634-2018
- **Recalling firm:** Vygon U.S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-28
- **Report date:** 2018-05-16
- **Termination date:** 2019-02-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lansdale, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1634-2018

## Citation

> AI Analytics. FDA recall Z-1634-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1634-2018. Source: US FDA. Licensed CC0.

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