EMOCLOT®, KLOTT®, PLASMACLOT® (Coagulation Factor FVIII), UMAN COMPLEX®, KEDCOM® (Prothrombin Complex), AIMAFIX®, KEDRIFIX® (Coagulation Factor FIX), ATKED® (Antithrombin III): Potential risk linked to incorrect sterilization of medical devices included into their secondary packaging.

Summary:

• Potential risk linked to incorrect sterilization of the BUTTERFLY NEEDLE (DEHP FREE) used for the administration of the medicinal product after its reconstitution with the solvent
• Potential risk linked to incorrect sterilization of the FILTER NEEDLE 16X3/4" used for the filtration of the reconstituted medicinal product before administration to the patient.
• As a precautionary measure it is requested to stop the use of such medical devices.
• Only the butterfly needle/filter needle included in the packaging is affected by the quality defect; the medicinal product itself can be used safely with an other device.
• Pharmacies should ensure that no medicinal products packs containing  the butterfly needle (DEHP FREE)/filter needle 16X3/4" are given to doctors or patients.