Cell Saver Elite Processing Kit — Class II medical device recall Z-0779-2019
Terminated recall by Haemonetics Corporation, reported 2019-02-06, distributed nationwide. Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell sal
| Recall number | Z-0779-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Haemonetics Corporation, Braintree, MA, United States |
| Recall initiated | 2017-08-02 |
| Classified | 2019-01-28 |
| Reported by FDA | 2019-02-06 |
| Terminated | 2020-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 4,576 units |
| Reason classes | packaging |
| Model numbers | CSE-P-70 |
Product
Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ System and 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
Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
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-0779-2019. 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.