Product Wiki · Recalls · Health Canada — Medical Devices

Infusion Sets — recall 59288

Health Canada — Medical Devices · Canada · 2019-05-16 · Type I

As described by Health Canada — Medical Devices: Infusion Sets - SS MF Low Sorbing, Low Sorb CV SS, CV SS, V/NV DP, V/NV CV SS DEHP Free, V/NV CKV SMS DP, V/NV CKV SS DP, Blood Set - NV, SmartSite Needle-Free Valve Port, Filter (2019-04-17)

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Agency
Health Canada — Medical Devices
Recall identifier
59288
Date of alert
2019-05-16
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Variation in the wall thickness of the administration sets' pumping segment may prevent the upper or lower occluders within the pump module from completely occluding the pump segment after the door is closed and the set's roller clamp is opened. This can result in flow inaccuracies through the pumping cycle process resulting in an over infusion.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/infusion-sets-ss-mf-low-sorbin

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