Unomedical Announces Manual Pulmonary Resuscitator Recall

Medical device maker Unomedical Inc. has announced a voluntary recall of some of its disposable manual resuscitators because the devices may be defective and unable to properly function as designed.

The Texas-based company and the Food and Drug Administration announced the recall of the medical devices manufactured between July 2002 and March 2008. Neither Unomedical nor the FDA said how many of the hand-held resuscitators are involved in the recall.

The recalled resuscitators are single-patient use devices used by healthcare professionals for patients requiring total or intermittent ventilatory support. However, the products may malfunction and “create a situation in which the use of the product could potentially cause serious adverse health consequences or death,” the company and FDA said.

Resuscitators with clear plastic retention rings below the right-angle exhalation port of the device are being recalled. Products with a blue retention ring and all products manufactured after March 2008 are not being recalled and do not need to be returned to the company, the FDA noted.

For pictures of the recalled products as well as those not involved in the recall, see the company’s press release.

Unomedical has sent notification letters to distributors and customers who purchased the recalled products to arrange for their return, the FDA said.

No related posts.