# FDA recall Z-0778-2019

> **Haemonetics Corporation** · Class II · device recall initiated 2017-08-02.

## Product

Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00    Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

## Reason for recall

Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.

## Distribution

US Nationwide Distribution to states of: AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, ME, MN, MO, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI.

## Key facts

- **Recall number:** Z-0778-2019
- **Recalling firm:** Haemonetics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-02
- **Report date:** 2019-02-06
- **Termination date:** 2020-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Braintree, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0778-2019

## Citation

> AI Analytics. FDA recall Z-0778-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0778-2019. Source: US FDA. Licensed CC0.

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