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: 2020-09-11
Affected Products
- PERCUTANEOUS NEONATAL PIGTAIL NEPHROSTOMY SET
- 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