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U.S. Department of Health and Human Services

Class 2 Device Recall Tissue Recovery Instrument Set

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  Class 2 Device Recall Tissue Recovery Instrument Set see related information
Date Initiated by Firm April 30, 2021
Create Date June 09, 2021
Recall Status1 Open3, Classified
Recall Number Z-1841-2021
Recall Event ID 87910
Product Classification General surgery tray - Product Code LRO
Product Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx.

Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation.
Code Information GTIN (01)10193489291186, lot numbers 21CDA959, 21BDB665, 21ADA390, and 20KDC285
Recalling Firm/
Manufacturer		 Medline Industries Inc
3 Lakes Dr
Northfield IL 60093-2753
Manufacturer Reason
for Recall		 The devices may not meet the minimum required sterility assurance level.
FDA Determined
Cause 2		 Software change control
Action The recalling firm, Medline Industries, Inc., issued an "IMMEDIATE ACTION REQUIRED RECALL" letter dated and emailed on 4/30/2021. The letter described the product, the reason for recall and actions to be taken. The consignees were instructed to immediately check their inventory for the affected product, complete and submit response form online to: Website link: https://recalls.medline.com; Recall Reference #: R-21-073; Recall Code: R5A2C566 , and quarantine it for subsequent return. 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 return any affected product to you for collection and return to Medline Industries, Inc. If you have any questions, please contact the Recall Department at 866-359-1704.
Quantity in Commerce 36/3-kit cases (108 kits)
Distribution US Distribution to state of: WI.
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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