Med-Rx Urological Cysto/Bladder Irrigation Set, Ref 10-4001 recallZ-0202-2023 · Canadian Hospital Specialties · initiated Aug 19, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Canadian Hospital Specialties or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The firm issued a MEDICAL DEVICE RECALL NOTICE to its consignees on 08/23/2022 by email. The notice explained the issue and requested the following: "TO IMPLEMENT THIS RECALL, PLEASE PERFORM THE FOLLOWING ACTIONS: 1.Examine your stock and determine if you have any affected product and lot. 2.Complete the attached Product Recall Response Form and send [email protected]. 3.Please report any affected units of the product to CHS for further instructions." For questions, contact: recalls @chsltd.com
Recall details
- Recall number
- Z-0202-2023
- Status
- Terminated
- Initiated by the company
- Aug 19, 2022
- Posted by the FDA
- Nov 11, 2022
- Recalling firm
- Canadian Hospital Specialties
- Quantity
- 9100 units
- Product code
- LJH
- FDA submissions
- K010607
- Distribution
- US
Product description
MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
Code information (models, lots, serial numbers)
UDI/DI: 00628725001050, Lot Numbers: 159603, exp 2026-12-01 and 166945, exp 2027-06-01
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MED-RX 10-4001Canadian Hospital Specialties Limited · System, Irrigation, Urological1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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