FDA Recall
Terminated
MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
Recall: Z-0202-2023
·
Initiated August 19, 2022
Recall
- Recall Number
- Z-0202-2023
- Event Number
- 90926
- Firm
- Canadian Hospital Specialties
- FEI Number
- 3932
- Product Code
- LJH
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 19, 2022
- Posted
- November 11, 2022
- Terminated
- March 20, 2023
- Address
- 2760 Brighton Rd, Oakville Canada
Description
MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
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.
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
Distribution
US
Quantity
9100 units