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.
FDA Recall Z-2721-2011 · Posted 2011-07-01
Advertisement
Recalling FirmCincinnati Sub-Zero Products Inc
Recall StatusTerminated
Product CodeDWJ
Date Initiated2011-05-02
Date Terminated2013-03-07
Product Quantity212 units - U. S. distribution & 44 units foreign distribution
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement