Recall Z-0901-2020— Haemonetics Corporation
Class II · Terminated
Class II FDA medical device recall by Haemonetics Corporation, initiated 2019-10-21, terminated 2020-11-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 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
Product description
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 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.