Dear Sir/Madam,
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:
1) Askina Gel 15gm (Code: 001419N) - all batch
2) Askina Calgitrol Paste 15gm (Code : 6241505) - all batch
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.
Sorry to any inconvenience caused and we would like to assure you that we have your best interest in mind.
Thank you.
Your sincerely,
Tan Jen Nie
Sales Manager
Mystique Wonder Sdn Bhd
