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:
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.