# FDA recall Z-0899-2020

> **Haemonetics Corporation** · Class II · device recall initiated 2019-10-21.

## Product

JAPAN DISP SET, 261J, 205J, 208 - Product Usage: 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. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorporeal circuit.

## Reason for recall

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB,  IT, CH.

## Key facts

- **Recall number:** Z-0899-2020
- **Recalling firm:** Haemonetics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-21
- **Report date:** 2020-02-05
- **Termination date:** 2020-11-06

- **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-0899-2020

## Citation

> AI Analytics. FDA recall Z-0899-2020. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0899-2020. Source: US FDA. Licensed CC0.

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