| 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 |
| For additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/Enforce/2003/ENF00798.html. Scroll down to “Recalls and Field Corrections: Devices – Class I”. |
Updated June 4, 2003
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