Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0901-2020 — Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell pr

U.S. FDA — Device Enforcement · United States · 2019-10-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0901-2020
Date of alert: 2019-10-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Haemonetics Corporation
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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