Field Safety Notice Intersurgical Various BVM Resuscitators (ICN 2987)

NHSSC: 40

Alert:

• Intersurgical has issued a Field Safety Notice regarding specific lots of various BVM Resuscitators.
• The supplier has identified during pre-use checks, some of the devices are missing one of the valves at the rear of the BVM Resuscitator.
• If the BVM has been supplied without the one valve that controls entrainment of atmospheric air, which would result in dilution of oxygen concentration and reduction of delivered FiO2.
• This does not have an impact upon the ability to provide adequate ventilation but does have an impact upon the ability to deliver the higher oxygen concentrations as detailed in the product instructions for use.
• This may result in negative impact upon clinical outcome during CPR.
• Intersurgicals investigation and evaluation of all available information has estimated the probability of failure rate to be 0.01% to 0.001% (1 in 10,000 to 1 in 100,000 products).

Products Affected:

• Three of the products affected are available from NHS Supply Chain:

• Ongoing supply of these products is not affected by this notice.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Identify any potentially affected products from the affected codes and lot numbers listed.
• Intersurgical advises:
  • All users must perform a thorough visual inspection before use of the products and lot numbers listed above, to confirm both one-way valves are present
  • Retain any affected sample(s) identified, and please report to Intersurgical immediately.
• Complete and return the Reply Form provided to priority@intersurgical.co.uk, to confirm receipt of this notice and that the necessary actions are being taken.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care team.

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.