# FDA recall Z-0122-2018

> **Halyard Health, Inc** · Class II · device recall initiated 2017-10-06.

## Product

Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit, 20 kits per case.

## Reason for recall

Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.

## Distribution

Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV

## Key facts

- **Recall number:** Z-0122-2018
- **Recalling firm:** Halyard Health, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-06
- **Report date:** 2017-11-29
- **Termination date:** 2020-09-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alpharetta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0122-2018

## Citation

> AI Analytics. FDA recall Z-0122-2018. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-0122-2018. Source: US FDA. Licensed CC0.

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