Haemonetics OrthoPAT System-Integrated Set — Class II medical device recall Z-2950-2018
Terminated recall by Haemonetics Corporation, reported 2018-09-05, distributed nationwide. OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the e
| Recall number | Z-2950-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Haemonetics Corporation, Braintree, MA, United States |
| Recall initiated | 2018-07-13 |
| Classified | 2018-08-30 |
| Reported by FDA | 2018-09-05 |
| Terminated | 2020-06-16 |
| Distributed | Nationwide (US) |
| Quantity | 432 units |
| Lot numbers | 1017049, 1017072, 1150H-00 |
Product
Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures
Reason for recall
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.
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-2950-2018. 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.