MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
FDA Recall Z-0202-2023 · Posted 2022-11-11
Recalling FirmCanadian Hospital Specialties
Recall StatusTerminated
Product CodeLJH
Date Initiated2022-08-19
Date Terminated2023-03-20
Product Quantity9100 units
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.
Firm 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
Root Cause
Nonconforming Material/Component
Distribution Pattern
US
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.