FDAClass IIINovember 23, 2022

Med-rx Urological Cysto/bladder Irrigation SET recall

MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001

Why was Med-rx Urological Cysto/bladder Irrigation SET recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI: 00628725001050, Lot Numbers: 159603, exp 2026-12-01 and 166945, exp 2027-06-01

Product
MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
Recalling firm
Canadian Hospital Specialties
Quantity
9100 units
Distribution
US
Recall date
November 23, 2022
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls