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U.S. Department of Health and Human Services

Class 2 Device Recall VP Tray with PVP, code DYNDA1928

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  Class 2 Device Recall VP Tray with PVP, code DYNDA1928 see related information
Date Initiated by Firm January 07, 2020
Create Date January 25, 2020
Recall Status1 Terminated 3 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 2		 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.
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