TEM Insufflation Tubing (2020-06-05) — recall 61407
Health Canada — Medical Devices · Canada · 2020-06-26 · Type II
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Reported risk: The TEM tube set consists of several tubes. With the pump hose from this set, it was found that the hose material used does not meet the dimensional specifications. The hose set is used in conjunction with a hose pump / roller pump. The way it works is based on an alternation of tension and relaxation of the flexible hose, which is pinched by rollers that rotate on a rotor. This draws medium into the hose and ejects it again. Due to the dimensional deviation, the the pump can no longer be guaranteed to function as specified.
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