# FDA recall Z-2950-2018

> **Haemonetics Corporation** · Class II · device recall initiated 2018-07-13.

## 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.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-2950-2018
- **Recalling firm:** Haemonetics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-13
- **Report date:** 2018-09-05
- **Termination date:** 2020-06-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Braintree, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2950-2018

## Citation

> AI Analytics. FDA recall Z-2950-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2950-2018. Source: US FDA. Licensed CC0.

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