FDA Device recall Z-0778-2019
Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related…
- FDA Device
- Class II
- terminated
- Published 2019-02-06
On 2019-02-06 the FDA classified a Class II recall of Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related… by Haemonetics, citing haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0778-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-02 |
| Published | 2019-02-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Haemonetics |
| Distribution | US |
Product
Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 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
Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
Identifiers
| code_info | Catalog number: 0291A-00, 0291E-00 |
|---|
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-0778-2019%22
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