Recall Z-0888-2020— Haemonetics Corporation
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: K932890. Product: CS5/5+ Fastpacks, 125 mL, 150¿ Res Autotransfusion Device - 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.. 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 recordK-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
CS5/5+ Fastpacks, 125 mL, 150¿ Res Autotransfusion Device - 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.
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.