MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
This recall has been terminated (originally issued November 11, 2022).
- Company
- Canadian Hospital Specialties
- Recall Initiated
- August 19, 2022
- Posted
- November 11, 2022
- Terminated
- March 20, 2023
- Recall Number
- Z-0202-2023
- Quantity
- 9100 units
- Firm Location
- Oakville Canada
- Official Source
- View on FDA website ↗
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.
Distribution
US
Lot / Code Info
UDI/DI: 00628725001050, Lot Numbers: 159603, exp 2026-12-01 and 166945, exp 2027-06-01
Root Cause
Nonconforming Material/Component
Action Taken
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