Product Wiki · Recalls · Health Canada — Medical Devices

Synchromed II - Programmable Pump — recall 44503

Health Canada — Medical Devices · Canada · 2017-09-11 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
44503
Date of alert
2017-09-11
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: The investigation report (IR) for Synchromed II pump corrosion defines the problem statement as the "Degradation of Synchromed II motor components due to corrosion, wear, and a combination of corrosion and wear can result in temporary, intermittent, and/or permanent motor stall." The root cause of failure is identified as the depletion of lubricant at the shaft/jewel bearing interface which initiates mechanical wear on shaft ends, resulting in wear particles that can mix with the remaining lubricant creating residue. Shaft wear results in temporary or permanent motor stall.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/synchromed-ii-programmable-pum

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