Field Safety Notice Timesco Healthcare Compower Silicone Manual Resuscitator Products (ICN 2266)

Alert:

• Manufacturer Xiamen Compower Medical Tech has issued a Field Safety Notice recalling specific Lot numbers of the Compower Silicone Manual Resuscitator Products.
• The Bag Valve Mask patient valve in devices with the affected Lot numbers may work loose, potentially causing the device, including the internal diaphragm, to fall apart.
• This will result in delaying lung ventilation to the patient.
• In addition to the Lot number the affected devices may be identified by the non-coloured product label with no circular red dot.
• Please see Appendix 1 TDM-RES-1500/1500W Identification Document.

Products Affected:

• The two product codes distributed by Timesco are available on NHS Supply Chain’s Blue Diamond Route:

• The supplier Timesco has advised this recall will not affect future supplies.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all affected products.
• Complete the form even if you do not have affected batch numbers by emailing: info@cpmedi.com
• Where affected product or Lot numbers are identified, please also contact your NHS Supply Chain Customer Service Advisor to arrange a return for full credit (reason code 7 Supplier Recall).
• All products are to be returned no later than Monday 25 September 2023.
• Where potential alternatives are identified, Customers are advised to consult their own clinical experts to ensure suitability for your organisation’s use of these products.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or Customer Relationship Manager.

Please be aware that in the event of a Field Safety Notice/Product Recall, we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.