Z-0778-2019Class II

Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell...

Name: Z-0778-2019 Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell...
Creator: Haemonetics Corporation
Published: 2017-08-02
License: https://open.fda.gov/license/

Haemonetics Corporation / initiated 2017-08-02 / Terminated / root cause: manufacturing process

FDA source

Haemonetics Corporation began a recall of Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components... on 2017-08-02. FDA classified it as Class II and gives the reason as "Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing". 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-0778-2019
Classification: Class II
Status: Terminated
Initiated: 2017-08-02
Posted: 2019-01-28
Terminated: 2020-08-06
Recalling firm: Haemonetics Corporation
Product: Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and 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.
Product code: CAC Apparatus, Autotransfusion
Reason for recall: Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On August 2, 2017, the firm, Haemonetics, sent a customer notification letter titled "URGENT Medical Device Recall for 70ml Centrifuge Bowls" to all customers. The letter informs the customers of the risk to health, actions to be taken and the product and distribution information. Action to be Taken by Customer: Please discontinue use of the products listed in the letter and return any unused product to Haemonetics. Contact your local customer service representative at 800-537-2802 to coordinate the return, shipment and credit receipt of unused product. Customers were also instructed to complete and return the RECALL ACKNOWLEDGEMENT FORM BY FAX TO +1-781-356-3558 OR SCAN AND E-MAIL TO [email protected]. Customers with questions or concerns are instructed to call the Customer Support Team at 800-537-2802 or email at [email protected].
Quantity in commerce: 11,208 units
Distribution: US Nationwide Distribution to states of: AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, ME, MN, MO, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI.
Product codes and lots: Catalog number: 0291A-00, 0291E-00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0778-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0778-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-06	2019-01-28
Z-0779-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-06	2019-01-28

Product code CAC

K014083Class IIHaemonetics Cell Saver 5 Autologous Blood Recovery SystemHaemonetics Corp. / cleared 2002-01-08

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)