FDA Device recall Z-2951-2018
Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs
- FDA Device
- Class II
- terminated
- Published 2018-09-05
On 2018-09-05 the FDA classified a Class II recall of Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs by Haemonetics, citing orthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the emptying of blood from the reservoirs. The inability to empty the rese….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2951-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-13 |
| Published | 2018-09-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Haemonetics |
| Distribution | US |
Product
Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures
Reason
OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the emptying of blood from the reservoirs. The inability to empty the reservoir means that the collected blood cannot be processed.
Identifiers
| code_info | Lot # 1117066 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2951-2018%22
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