Recall Z-0202-2023— Canadian Hospital Specialties

Name: FDA recall Z-0202-2023
Creator: U.S. Food and Drug Administration
Published: 2022-08-19

Class III · Terminated

Class III FDA medical device recall by Canadian Hospital Specialties, initiated 2022-08-19, terminated 2023-03-20. It names one FDA 510(k) clearance: K010607. Product: 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..

Recalling firm: Canadian Hospital Specialties
Classification: Class III
Status: Terminated
Initiated: 2022-08-19
Terminated: 2023-03-20
Firm location: Oakville, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K010607 — MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001Benlan, Inc.·cleared 2001-11-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.