Product Recall Medtronic Mac 2 Disposable Video Laryngoscope Plastic Blade FSM1957 (ICN 2252)

Alert:

• The supplier Medtronic has issued a Product Recall for specific product lots of McGrath MAC 2 disposable laryngoscope blades.
• Medtronic have investigated and identified a manufacturing issue which resulted in an ineffective application of the anti-fog agent on the blades. An ineffective application of the anti-fog coating can result in condensation accumulating on the blade during use, resulting in the image on the video laryngoscope screen being blurred or obscured.

Products Affected:

• Of the products affected, NHS Supply Chain has supplied one:

• Please note that only the two Lot numbers listed above are affected.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Please complete and return the verification form even if you do not have the affected Lots by emailing it to compliance@hc21.group
• HC21 will arrange a collection of the affected Lot numbers.
• Please also contact your local NHS Supply Chain Customer Service Advisor with full details of affected products including National Product Code, Lot numbers and quantity stating whether box 50 or eaches, to enable us to support, or raise credit if appropriate.
• 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.

Please be aware that in the event of a Field Safety Notice or 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.