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U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE MICROKILL

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  Class 2 Device Recall MEDLINE MICROKILL see related information
Date Initiated by Firm June 29, 2022
Create Date August 02, 2022
Recall Status1 Open3, Classified
Recall Number Z-1493-2022
Recall Event ID 90558
Product Classification Disinfectant, medical devices - Product Code LRJ
Product MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351420ANH, MSC351420ANZ, MSC351430A, MSC351430AZ
Code Information Lot numbers 0546 through 3126 (this represents all lot numbers)
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Kassandra Cotner
266-359-1704
Manufacturer Reason
for Recall		 stability failure
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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