ECMO Heaters Model 333W, 115V - Part #86135, and 230V & 240V - Part #86136, Cardiopulmonary by-pass temperature controll

FDA device recall Z-1656-2012 · posted 2012-05-24 · Terminated

Recall details

Recalling firm

Cincinnati Sub-Zero Products Inc

Reason for recall

Design error. 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 one another. If this situation occurs, a Service Technician, Operator/User, and/or Patient could be exposed to electric shock during device servicing or use. This situation was ori

Action taken

Cincinnati Sub-Zero (CSZ) issued an 'URGENT Medical Device Field Action Letter to their customers dated January 31, 2012. The letter was mailed out starting on February 3, 2012. The letter includes: a description of the product and problem, describes the affected Serial Number Range subject to recall/correction and instructs the customers to discontinue using the affected serial-numbered units.The customers are instructed to return the product to their Service Department or Biomedical Engineering Dept. for correction and to complete and mail to CSZ the attached 'Field Action Form.' For additional information, the firm can be reached on a toll-free # 1-800-989-7373.

Root cause

Device Design

Status

Terminated

Product code

DWJ

Quantity affected

298 units (115V=295 and 230V/240V=3)

Distribution

AL, AR. AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL,K IN,, KS, LA, MA, MD, MI, MN, MO, NC, NE, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI

Date initiated

2012-02-03

Date posted

2012-05-24

Date terminated

2013-02-26

Location

Cincinnati, OH