MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
Summary
The FDA issued a Class III for MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001 by Canadian Hospital Specialties. Reason: Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible barcode which prevents successful scanning of the pack.
Details
Source
Device Recall
External ID
Z-0202-2023
Action Date
2022-11-23
Status
Terminated
Category
device
Product Description
MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
Lot/Code Info: UDI/DI: 00628725001050, Lot Numbers: 159603, exp 2026-12-01 and 166945, exp 2027-06-01
Quantity Affected: 9100 units
Reason for Recall
Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible barcode which prevents successful scanning of the package.
Distribution
US
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-19
Company
Oakville, N/A
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Canadian Hospital Specialties) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Canadian Hospital Specialties have FDA actions?
This is the only FDA action we have on record for Canadian Hospital Specialties in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0202-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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