Ordinary off the shelf alcohol products are Isopropyl based, or Ethanol based. Ethanol is very effective against viruses, but has limited effect on Bacteria. Isopropyl on the other hand is not as effective against viruses as Ethanol, but it has some bacteria killing action and some virus killing action, making it a good compromise. Softa-Man® is not about compromise. Softa-Man® is a combination of Ethanol and the highly effective anti-bacterial N-Propanol and this makes it more effective against a much broader spectrum of viruses and bacteria than any off the shelf brand, and even other hospital grade brands.
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On behalf of Bbraun Medical Supplies Sdn Bhd, the Manufacturer and Mystique Wonder Sdn Bhd, we are initiating a recall of the following products in the content of a FIELD SAFETY CORRECTION ACTION from the market:
In the manufacturing site it was determined that the irradiation dose qualified for sterilisation on the above mentioned products was too low. In consequence, the germ reduction through gamma irradiation may not have reached the required sterility
assurance level of 10-6. The effect can not be limited to specific batches.
Up to now, we received no market feedback on any adverse patient outcome which could be associated to the above described observation. However, Bbraun and Mystique Wonder have decided to recall the affected products form the market as a
preventive measure.
We kindly ask you to initiate the following activities immediately and with priority:
Identify, quarantine and return the affected devices
Do not use the affected devices anymore
Patients with affected device in use should be monitored carefully. If clinically uneventful, an exchange of the product is not indicated.
Inform the responsible personnel in the affected facilities
Confirm the receipt of the information and the balance of the affected product in the hospital.
Alternatively, you may also contact us at 60-4 3973392 ( Monday to Friday, 8.30am - 5.30pm).
Sorry to any inconvenience caused and we would like to assure you that we have your best interest in mind.