Recall Z-0895-2020— Haemonetics Corporation

Name: FDA recall Z-0895-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-21

Class II · Terminated

Class II FDA medical device recall by Haemonetics Corporation, initiated 2019-10-21, terminated 2020-11-06. It names one FDA 510(k) clearance: K101907. Product: CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - 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 product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.. Reason: 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..

Recalling firm: Haemonetics Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-10-21
Terminated: 2020-11-06
Firm location: Braintree, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K101907 — HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEMHaemonetics Corp.·cleared 2010-12-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - 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 product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.