JAPAN CS ELITE FASTPACK — Class II medical device recall Z-0902-2020
Terminated recall by Haemonetics Corporation, reported 2020-02-05, distributed nationwide. Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225m
| Recall number | Z-0902-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Haemonetics Corporation, Braintree, MA, United States |
| Recall initiated | 2019-10-21 |
| Classified | 2020-01-29 |
| Reported by FDA | 2020-02-05 |
| Terminated | 2020-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 8,114 |
| Reason classes | packaging |
| Lot numbers | 1118017-0219057190124H10119084, 1118017-1118031181226H11118019, 1118017-1118031181226H11118063, 1118017-1118032181226H11118063, 1118017-1118081190124H10119084, 1118017-1118082190124H10119002, 1118017-1118082190124H20119002, 1118017-1118083190124H20119084 |
| Model numbers | CSE-FP-225V-JA |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0902-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.