FDA Device recall Z-0895-2020
CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover…
- FDA Device
- Class II
- terminated
- Published 2020-02-05
On 2020-02-05 the FDA classified a Class II recall of CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover… by Haemonetics, citing 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 bow….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0895-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-21 |
| Published | 2020-02-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Haemonetics |
| Distribution | US |
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.
Identifiers
| code_info | Catalog number/FG Item Number: CSE-FP-225V 1. Specific Lots with Bowl Cracks (7636 Distributed) Lot number: 1902009…Catalog number/FG Item Number: CSE-FP-225V 1. Specific Lots with Bowl Cracks (7636 Distributed) Lot number: 1902009HTT 1903001HTT 1903004HTT 1804008HTT 1804010HTT 1805004HTT 1805005HTT 1812012HTT 1901004HTT 1901005HTT 1901006HTT 1808007HTT 1808009HTT 1808012HTT 1809001HTT 1809002HTT 1809006HTT 1809009HTT 1810001HTT 1810003HTT 1901005HTT 1902009HTT 1810006HTT 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0895-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.