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U.S. Department of Health and Human Services

Class 2 Device Recall Controls, Trilevel, Serum Matrix Free

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  Class 2 Device Recall Controls, Trilevel, Serum Matrix Free see related information
Date Initiated by Firm November 30, 2021
Create Date December 21, 2021
Recall Status1 Terminated 3 on January 06, 2023
Recall Number Z-0404-2022
Recall Event ID 89150
Product Classification Drug mixture control materials - Product Code DIF
Product Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
Code Information Model No.: S-O2460605; Batch No.: 161603, 165148, 156205, 158144, 169124, 171961, and 175250; Serial No.:161603, 165148, 156205, 158144, 169124, 171961, and 175250.
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Kassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		 Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
FDA Determined
Cause 2		 Storage
Action The firm distributed an Urgent Recall Notification, dated 11/30/2021, to customers who purchased recalled product via first class mail. The notification informs customers that the firm is initiating a removal of Trilevel Serum Matrix Free from S-O2460605 kits due to product being compromised during shipment. Customers are instructed to immediately check their stock for affected product, quarantine any lot numbers associated with the recall, and destroy affected product. Customers were provided an Urgent Remedial Action Destruction Form to complete and return to the firm to indicate whether or not they possess recalled product and document product destruction. Completed forms are to be returned to the firm via email at recalls@medline.com or by fax at 866-767-1290. If product was further distributed, customers are required to share the recall notification down the distribution chain. Customers with any questions about the recall are instructed to call 866-359-1704.
Quantity in Commerce 14 units (individual)
Distribution US Nationwide distribution in the states of IL, OH, MS, and PA.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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