Z-0202-2023Class III

Med-Rx Urological Cysto/bladder Irrigation Set, Ref 10-4001

Name: Z-0202-2023 Med-Rx Urological Cysto/bladder Irrigation Set, Ref 10-4001
Creator: Canadian Hospital Specialties
Published: 2022-08-19
License: https://open.fda.gov/license/

Canadian Hospital Specialties Ltd. / initiated 2022-08-19 / Terminated / root cause: manufacturing process

FDA source

Canadian Hospital Specialties began a recall of MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001 on 2022-08-19. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0202-2023
Classification: Class III
Status: Terminated
Initiated: 2022-08-19
Posted: 2022-11-11
Terminated: 2023-03-20
Recalling firm: Canadian Hospital Specialties Ltd.
Product: Med-Rx Urological Cysto/bladder Irrigation Set, Ref 10-4001
Product code: LJH System, Irrigation, Urological
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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
Quantity in commerce: 9100 units
Distribution: US
Product codes and lots: UDI/DI: 00628725001050, Lot Numbers: 159603, exp 2026-12-01 and 166945, exp 2027-06-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0202-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0202-2023	Class III	Terminated	Voluntary: Firm initiated	2022-11-23	2022-11-11

Product code LJH

K010607Class IIMed-Rx Irrigation Set, Model 10-3001, 10-3002, 10-4000, 10-4001Benlan, Inc. / cleared 2001-11-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)