Alerta De Seguridad para breathing system components

Safety alert

2011-10-11

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20111011.html

Mhra field safety notice: breathing system components the uk medicines and healthcare products regulatory agency (mhra) issued a field safety notice to alert healthcare providers and customers that some products manufactured by unomedical-a convatec company should not be used. according to the manufacturer, there was a logistical error that has occurred in a small number of their medical devices. these devices have been shipped to customers after their intended shelf life has passed and should not be used. the involved devices are: ‧ high vac 600ml bottle with drain and trocar, connecting tube & nrv, ch18 ‧ high vac 600ml bottle with drain and trocar, connecting tube and nrv, ch14 ‧ tracheostomy mask, paediatric ‧ up-mist nebulizer, with "t piece", mouth piece and 2.1m oxygen tubing, adult ‧ ecoclip-3 three of the lots sold past expiry are sterile products. since it cannot be certain that the devices will continue to remain both safe and efficacious in accordance with their intended use, the manufacturer is recalling all the affected devices. the affected devices can be identified by product lot number in conjunction with the product reference number. the lot number and reference number can be found on the device label which is located on both the primary packaging as well as the shipping carton. the affected products are identified as below: product description sterile product? lot number nhs supply chain catalogue codes 26057018 high vac 600ml bottle with drain and trocar, connecting tube & nrv, ch18 yes 040424 n/a 041116 26057014 high vac 600ml bottle with drain and trocar, connecting tube & nrv, ch14 yes 041110 fwx119 246mm tracheostomy mask, paediatric no 03-36 n/a 952mm up-mist nebulizer, with "t piece" mouth piece and 2.1m oxygen tubing, adult no 05-49 fde394 1110130970 ecoclip-3 (this device has now been discontinued) no 4777/4 n/a for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/ index.Htm if you are in possession of the affected products, please stop using them and contact your supplier for necessary actions.