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U.S. Department of Health and Human Services

Medical Devices

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Portex Resuscitator

Class I Recall
Date Recall
Initiated
November 15, 2002
Product:
Portex 1st Response Adult Manual Resuscitator
Use:
This manual ventilator is used as a breathing-assist device intended to provide respiratory support to patients suffering breathing distress and whose body weight is 55 lbs. (25 kg) or more.
Recalling Firm:
Sims Portex Inc.
10 Bowman Drive
Keene, New Hampshire 03431
Reason for Recall:
The preset positive expiratory end pressure (PEEP) valve was set to its maximum pressure of 20 cm H20 and could result in patient injury if the product label was not read and product not adjusted at the time of use. There have been at least two patient injuries requiring patients to be placed on a ventilator due to the inadvertent delivery of excess PEEP during resuscitation attempts.
Public Contact:
Timothy J. Talbott
Director of Regulatory Affairs
Portex, Inc.
603-352-3812
FDA District:
New England
FDA Comment:
There is a reasonable probability that use of the product will cause serious adverse health consequences