FDA Device recall Z-0900-2020
JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing o…
- FDA Device
- Class II
- terminated
- Published 2020-02-05
On 2020-02-05 the FDA classified a Class II recall of JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing o… 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-0900-2020 |
| 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 DISP SET, 261J, 205J, HAR - Product Usage: 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. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorporeal circuit.
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: 261J-SS-SET 1. Specific Lots with Bowl Cracks (17 Distributed) Lot number: 1118011-1…Catalog number/FG Item Number: 261J-SS-SET 1. Specific Lots with Bowl Cracks (17 Distributed) Lot number: 1118011-111808108170710119002 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-0900-2020%22
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