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

FDA device recall Z-2721-2011 · posted 2011-07-01 · Terminated

Recall details

Recalling firm

Cincinnati Sub-Zero Products Inc

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

DWJ

Quantity affected

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,

Date initiated

2011-05-02

Date posted

2011-07-01

Date terminated

2013-03-07

Location

Cincinnati, OH

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