Product Wiki · Recalls · Health Canada — Medical Devices

Cook Inc. catheters, catheter sets and accessories (2016-04-19) — recall 55082

Health Canada — Medical Devices · Canada · 2016-04-27 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
55082
Date of alert
2016-04-27
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Cook Medical has identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Their preliminary investigation into this matter has identified that environmental conditions, such as storage temperature, humidity, and the use of vaporized hydrogen peroxide (VHP) for whole-room decontamination within healthcare facilities, may be contributing to the occurrence. There may also be other undetermined contributors to this issue. Investigation is ongoing. Potential adverse events that may occur as a result of catheter polymer degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cook-inc-catheters-catheter-se

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