Z-0891-2020Class II

Cell Saver5/5+ Bowl Kit (225 ml) Autotransfusion Device -

Name: Z-0891-2020 Cell Saver5/5+ Bowl Kit (225 ml) Autotransfusion Device -
Creator: Haemonetics Corporation
Published: 2019-10-21
License: https://open.fda.gov/license/

Haemonetics Corporation / initiated 2019-10-21 / Terminated / root cause: design

FDA source

Haemonetics Corporation began a recall of Cell Saver5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and... on 2019-10-21. FDA classified it as Class II and gives the reason as "Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0891-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-21
Posted: 2020-01-29
Terminated: 2020-11-06
Recalling firm: Haemonetics Corporation
Product: Cell Saver5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: 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: Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.
Root cause tag: design
FDA root cause: Device Design
Action: On October 21 & 22, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail: SAFETY NOTIFICATION FOR 125ml and 225ml Centrifuge Bowls Attention: Risk Management Director, Materials Manager and Director Biomedical Engineering Please forward this communication to all potential users of the products. Dear Customer, Haemonetics makes continuous efforts to supply our customers with products that meet the highest levels of product quality and reliability. We have recently identified a potential issue with Cell Saver 5/5+ and Cell Saver Elite/Elite + 125ml and 225ml bowl sets. The investigation has determined that a small number of bowl sets may have the potential to develop leaks at the inner core, which could result in fluid becoming trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. Note: The likelihood of experiencing an inner core leak is low, and no fluid has been found to exit the bowl into the Cell Saver device. We have a dedicated team implementing corrective actions to resolve this issue. What to do if experiencing Long Empty error code on your device: If an error code indicates Long Empty, complete the troubleshooting guidance provided on Page 3 in this communication. If the error message continues, the user should remove the bowl, tilt it upside down and visually check the base for cracks directly on or extending from the ribs. See Page 4 for photo example of where to inspect: -If no cracks are observed and procedure is complete, proceed with using the blood in the reinfusion bag. No further action is required. If continuing with the procedure, use a new processing set. - If cracks are confirmed, the user should assume incomplete washing of the bowl contents, and the wash cycle should be repeated on blood that is in the reinfusion bag. Take any residual RBCs in the reinfusion bag, and empty its contents into the cardiotomy reservoir to rep
Quantity in commerce: 690043
Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.
Product codes and lots: Catalog number/FG Item Number: 00263-00 1. Specific Lots with Bowl Cracks (44831 Distributed) Lot number: 0119010 0119011 0219031 0218056 0218057 0218058 0418012 1018084 1118009 0718099 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0891-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0885-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0886-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0887-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0888-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0889-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0890-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0891-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0892-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0893-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0894-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0895-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0896-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0897-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0898-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0899-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0900-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0901-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0902-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0903-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0904-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0905-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0906-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29

Product code CAC

K932890Class IICell Saver 5 SystemHaemonetics Corp. / cleared 1994-01-05

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)