Class 2 Device Recall VP Tray with PVP, code DYNDA1928

• Date Initiated by Firm: January 07, 2020
• Create Date: January 25, 2020
• Recall Status: Terminated on September 16, 2020
• Recall Number: Z-0865-2020
• Recall Event ID: 84665
• Product Classification: Tray, surgical - Product Code LRP
• Product: Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10)0000000000 (17)000000(30)20 Packaged for Medline Industries, Inc., Northfield, IL 60093 USA. 1-800-MEDLINE www.medline.com WINGED SPONGE:Made in Mexico
• Code Information: Code DYNDA1928 Lot Number: 2019032190 Expiration Date 07/31/2020
• Recalling Firm/ Manufacturer: Medline Industries Inc; Three Lakes Drive; Northfield IL 60093
• For Additional Information Contact: Kassandra Cotner; 866-359-1704
• Manufacturer Reason for Recall: There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.
• FDA Determined Cause: Packaging
• Action: Consignees notified by first class mail with formal recall letter dated January 07, 2020. The letter identified affected product, stated reason for recall, and requested product to be quarantined. A response form was requested to be returned via email.
• Quantity in Commerce: 500
• Distribution: Kentucky. No governmental, Canadian, or Mexican consignees.
• 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.