Z-2721-2011

ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. This device is intended to provide...

Name: Z-2721-2011 ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. This device is intended to provide...
Creator: Cincinnati Sub-Zero Products Inc
Published: 2011-05-02
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2011-05-02 / Terminated / root cause: design

FDA source

Cincinnati Sub-Zero Products Inc began a recall of ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. This device is intended to provide temperature-controlled warm water flow to a blood... on 2011-05-02. The reason FDA records is "The probe jack contacts (terminals) on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other...". 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-2721-2011
Status: Terminated
Initiated: 2011-05-02
Posted: 2011-07-01
Terminated: 2013-03-07
Recalling firm: Gentherm Medical, LLC
Product: ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient's blood temperature. It can be used during extracorporeal circulation procedures. It is intended to use with commercially available heat exchangers.
Product code: DWJ System, Thermal Regulating
Reason for recall: The probe jack contacts (terminals) on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. If this situation occurs, the service technician, user, and/or patient could be exposed to electric shock during servicing and/or use.
Root cause tag: design
FDA root cause: Device Design
Action: Cincinnati Sub-Zero Products Inc issued an "Urgeant Medical Device Field Action" letter on May 2, 2011 to all affected customers. The letter includes; description of product and problem, affected lots and instructs customers to discontinue its use. The product is to be returned to the Service Department for an update and the customer is instructed to complete and mail Field Action Form. For additional contact the firm at 1-800-989-7373 or (513) 772-8810.
Quantity in commerce: 212 units - U. S. distribution & 44 units foreign distribution
Distribution: Worldwide Distribution and countries of The Netherlands, Kuwait, India, Saudi Arabia, Taiwan and Australia. (USA) Nationwide including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, LA, MA, MD, MI, MIN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, WA, and WI.
Product codes and lots: Model: 333W Part Number: 86135 (115V), 86136 (230V) and 86138 (240V) Serial Number: 942-E2979 through 031-E5150

Product code DWJ

K811742Class IIHemotherm Model 400Cincinnati Sub-Zero / cleared 1981-08-13

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)