Z-2950-2018Class II

Haemonetics OrthoPAT System-Integrated Set

Name: Z-2950-2018 Haemonetics OrthoPAT System-Integrated Set
Creator: Haemonetics Corporation
Published: 2018-07-13
License: https://open.fda.gov/license/

Haemonetics Corporation / initiated 2018-07-13 / Terminated / root cause: manufacturing process

FDA source

Haemonetics Corporation began a recall of Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs... on 2018-07-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2950-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-13
Posted: 2018-08-30
Terminated: 2020-06-16
Recalling firm: Haemonetics Corporation
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
Product code: CAC Apparatus, Autotransfusion
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Haemonetics, notified customers by an email titled "URGENT: MEDICAL DEVICE RECALL" on July 13, 2018 . The email described the product, problem, and actions to be taken. The customers were instructed to inspect product for defect and return units of the affected lots for replacement with non-affected units; complete the attached customer acknowledgement form via FAX TO +1-781-356-3558 OR SCAN AND E-MAIL TO: [email protected]. You can contact your local customer service representative at: North America 1.800.537.2802 or email:[email protected].
Quantity in commerce: 432 units
Distribution: US Nationwide Distribution
Product codes and lots: Lot # 1017049 , 1150H-00, 1017072

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2950-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2950-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-30
Z-2951-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-30

Product code CAC

K992723Class IIOrthopedic Perioperative Autotransfusion (Orthopat) SystemTransfusion Technologies Corp. / cleared 1999-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)