Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1493-2022Class II

MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351420ANH, MSC351420ANZ...

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-06-29 / Open, Classified

MEDLINE INDUSTRIES, LP - Northfield began a recall of MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351420ANH, MSC351420ANZ, MSC351430A, MSC351430AZ on . FDA classified it as Class II and gives the reason as "stability failure". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-1493-2022
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351420ANH, MSC351420ANZ, MSC351430A, MSC351430AZ
Product code
LRJ Disinfectant, Medical Devices
Reason for recall
stability failure
FDA root cause
Under Investigation by firm
Action
The firm sent a recall notice to consignees on 06/29/2022 by US Mail. The notices explained the issue and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-22-073 Recall Code: RXXXXXXX 3.Upon completion of the form, please destroy affected product. Your account will receive credit once the response form is submitted. 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers document and destroy any affected product. You should include your customers quantities on your response form. If you have any questions, please contact the Recall Department at 866-359-1704."
Quantity in commerce
6119500 wipes
Distribution
US Nationwide distribution.
Product codes and lots
Lot numbers 0546 through 3126 (this represents all lot numbers)

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1493-2022
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1493-2022Class IIOngoingVoluntary: Firm initiated