Field Safety Notice Medicare Colgate Vaginal Speculum FPH85101, FPH85102, FPH85103, FPH85104 and FPH85105 (ICN 3452)

NHSSC: 53

Alert:

• Medicare Colgate has issued Field Safety Notice NC2026/62 following a report of foreign objects found in the sterile sealed package of Cusco vaginal specula.
• An investigation by Medicare Colgate found further products from two Lot numbers with this issue.
• If a product containing a foreign object is used on a patient there is a risk of introducing the foreign body into the sterile field or patient tissue.

Products Affected:

• Five product codes are affected.
• The five products affected were available via NHS Supply Chain’s eDirect Service.
• These products are currently suspended and unavailable to order.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• Please note only Lot numbers 241025 and 260405 as quoted in the Field Safety Notice are affected.

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 Lot numbers.
• Complete the FSN Acknowledgement and Response Form, page 3 of the Field Safety Notice, and email to: daniel@sterifedd.com. On receipt of the completed form Medicare Colgate will arrange to collect the affected products.
• Please also contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products for return to Medicare Colgate, including National Product Code (NPC), Lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number and raise your credit as appropriate.
• Where potential alternatives are identified, customers are advised to consult your 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 the Acute 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.