Unomedical Issues Resuscitator Recall

Unomedical is voluntarily recalling certain units of the single-opatient use Manual Pulmonary Resuscitator (MPR), which is intended for patients requiring ventilatory support. according to the device manufacturer.

The recall only impacts MPRs manufactured from July 2002 to March 2008 and matching the lot numbers listed at http://www.unomedical.com/?pageid=H3160.

The recall is being conducted because of a potential malfunction of certain MPR units, which may impair the ability of the device to generate the positive pressure necessary to function properly. The occurrence of such a malfunction may create a situation in which the use of the product could potentially cause serious adverse health consequences or death, the McAllen, Texas-based firm said.

Unomedical is contacting customers to arrange for the return and credit of all MPR units subject to this recall by sending notification letters to distributors and customers.

In order to distinguish between the recalled product and unaffected product, customers may examine the patient valve housing below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned to Unomedical. MPR units with a clearly visible blue retention ring are not affected and do not need to be returned.