FDA Medical Device Recalls (openFDA)
Canadian Hospital Specialties: MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
- Recall number
- Z-0202-2023
- Recalling firm
- Canadian Hospital Specialties
- Product
- MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
- Status
- Terminated
- Initiated
- 2022-08-19
- Posted
- 2022-11-11
- Terminated
- 2023-03-20
- 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 package.
- 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 torecalls@chsltd.com. 3.Please report any affected units of the product to CHS for further instructions." For questions, contact: recalls @chsltd.com
- Quantity
- 9100 units
- Distribution
- US
- Lot, serial or model codes
- UDI/DI: 00628725001050, Lot Numbers: 159603, exp 2026-12-01 and 166945, exp 2027-06-01
- 510(k) numbers
- ["K010607"]
- PMA numbers
- not on file
- Product code
- LJH
- Firm FEI
- 3932
- Firm city
- Oakville
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28