FDA Device recall Z-0902-2020
JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subse…
- FDA Device
- Class II
- terminated
- Published 2020-02-05
On 2020-02-05 the FDA classified a Class II recall of JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subse… 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-0902-2020 |
| 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
JAPAN CS ELITE FASTPACK, 225ML - 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-JA 1. Specific Lots with Bowl Cracks (1249 Distributed) FP Lot numbers:…Catalog number/FG Item Number: CSE-FP-225V-JA 1. Specific Lots with Bowl Cracks (1249 Distributed) FP Lot numbers: 1118017-0219057190124H10119084; 1118017-1118031181226H11118019; 1118017-1118031181226H11118063; 1118017-1118032181226H11118063; 1118017-1118081190124H10119084; 1118017-1118082190124H10119002; 1118017-1118082190124H20119002; 1118017-1118083190124H20119084 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-0902-2020%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.