Product Wiki · Recalls · Health Canada — Medical Devices

PERCUTANEOUS PIGTAIL NEPHROSTOMY SET (2020-08-31) — recall 61595

Health Canada — Medical Devices · Canada · 2020-09-11 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
61595
Date of alert
2020-09-11
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. If a catheter is left indwelling longer than 4 weeks, there is an increased potential for breakage, kinking, encrustation, migration, and/or infection to occur. Potential adverse events that may result from these hazards include discomfort, additional intervention, hydronephrosis, and loss of kidney function.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/percutaneous-pigtail-nephrosto

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