The following products have been recalled:
Alicn non-contact thermometer // AET-R1B1
Product drawbacks:
- The packaging does not show the date of production and the identity of the EU authorised representative.
- On the declaration of conformity, the name of the product is different from the one on the packaging and on the device.
MSafe medical protective gown PPPE
Product drawbacks:
- No packaging and no labelling.
- It is not possible to link a declaration of conformity to a device.
MSafe surgical gown SMMS
Product drawbacks:
- There is no CE marking on the equipment.
- EU authorised representative details (name and address) are missing.
- The device was distributed on the basis of a false document.
Children’s masks Type IIR, medical 25pcs per pack, A1 Air 0726754936678
Product drawbacks:
- There is no indication on the device label that the device is a medical device.
- The declaration of compliance does not meet the requirements of the MDR.
Medical Protective Masks, TYPE IIR, 50pcs per pack, A1 Air 0726754936616
Product drawbacks:
- The declaration of compliance does not meet the requirements of the MDR.
- There is no indication on the device label that the device is a medical device.
Surgical masks TYPE IIR, 5pcs, MSafe 6973324710020
Product drawbacks:
- There is no information on the packaging on the date up to which the device can be used safely and/or the date of manufacture.
Surgical masks TYPE IIR, 10pcs, MSafe 6973324710013
Product drawbacks:
- There is no information on the packaging on the date up to which the device can be used safely and/or the date of manufacture.
Surgical masks Type IIR, 50pcs, RED APPLE (blue)
Product drawbacks:
- According to the information on the device, it is both a medical device and a personal protective equipment.
- The device does not meet the requirements for a medical device.
- No notified body for personal protective equipment is involved.
- The declaration of conformity is not linked to the product.
Surgical masks Type IIR, 50pcs, RED APPLE (black)
Product drawbacks:
- There is no indication on the device label that the device is a medical device.
- The declaration of conformity is not linked to the product.
Surgical masks TYPE IIR, 50pcs, MSafe MSAFE50
Product drawbacks:
- The declaration of compliance does not meet the requirements of the MDR.
- There is no indication on the label that the device is a medical device.
To exchange products, please write to: info@medifum.ee
