PERCUTANEOUS PIGTAIL NEPHROSTOMY SET (2020-08-31)

Starting date:
August 31, 2020
Posting date:
September 11, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73899

Last updated:

Affected Products

  1. PERCUTANEOUS NEONATAL PIGTAIL NEPHROSTOMY SET
  2. PERCUTANEOUS PIGTAIL NEPHROSTOMY SETS WITH CATHETERS

Reason

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.

Affected products

A. PERCUTANEOUS NEONATAL PIGTAIL NEPHROSTOMY SET

Lot or serial number

All lots.

Model or catalog number
  • 80106
Companies
Manufacturer
Cook, Inc.
750 Daniels Way
Bloomington, Indiana
47404
UNITED STATES

B. PERCUTANEOUS PIGTAIL NEPHROSTOMY SETS WITH CATHETERS

Lot or serial number

All lots.

Model or catalog number
  • 080208-S6
Companies
Manufacturer
Cook, Inc.
750 Daniels Way
Bloomington, Indiana
47404
UNITED STATES