Perfusion Pack, Custom Pack with SOFTLINE, Perfusion Set (with… — recall 59229
Health Canada — Medical Devices · Canada · 2019-03-15 · Type II
As described by Health Canada — Medical Devices: Perfusion Pack, Custom Pack with SOFTLINE, Perfusion Set (with SOFTLINE, BIOLINE Coating) (2019-02-19)
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Reported risk: Maquet Cardiopulmonary has been informed that the printed information on the front and back side of the pre-bypass filter, showed incomplete print quality. Internal investigations have revealed that the print on the filters had already been partially removed out of the packaging or it was also detected that the printing could be removed by touching with hands. The print does not necessarily come off during transport. Even if the print is still fully intact it could be an affected device. The print may be removed when touched without any solvent used.
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