Alerta De Seguridad para Ventlab manual resuscitators

Safety alert

2012-10-24

2012-10-24

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20121024.html

Medical device safety alert: ventlab manual resuscitators the united states food and drug administration (fda) has posted a firm press release concerning ventlab manual resuscitators distributed between march 2012 and july 2012. ventlab corporation, the device manufacturer, initiated a nationwide recall of 14,602 of its manual resuscitators. the manual resuscitators, as listed below have been found to potentially deliver little to no air/oxygen through the patient valve to the patient, which could result in life threatening health consequences that include hypoxia and hypoventilation. the recall includes the following product models: ventlab airflow adult resuscitator ventlab airflow infant resuscitator ventlab airflow small adult resuscitator ventlab statcheck adult resuscitator ventlab safespot infant resuscitator ventlab premium infant resuscitator ventlab premium small child resuscitator ventlab premium small adult resuscitator ventlab rescuemed infant resuscitator breathtech safespot infant resuscitator provider enterprises safespot infant resuscitator provider enterprises adult resuscitator the manufacturer voluntarily recalled the above listed products after becoming aware of a product incident where the nature of the complaint was that the resuscitators were delivering little or no air through the patient valve to the patient. no injuries have been reported to-date. end users who have these manual resuscitators should stop using them and immediately contact ventlab corporation or your supplier for further instructions on the return of these products. for details, please refer to the following fda website http://www.Fda.Gov/safety/recalls/ucm324561.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 24 october 2012.