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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile Esmark Bandage, 3 x 9

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  Class 2 Device Recall Sterile Esmark Bandage, 3 x 9 see related information
Date Initiated by Firm July 18, 2017
Create Date December 29, 2017
Recall Status1 Terminated 3 on April 24, 2020
Recall Number Z-0295-2018
Recall Event ID 78360
Product Classification Bandage, elastic - Product Code FQM
Product Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, 20 individually packed bandages per case.
Code Information Model No. DYNJ05914, Lots: 17GB3101, 172B2025, 17FB9612, 17QB8614
Recalling Firm/
Manufacturer		 Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
For Additional Information Contact Brad Schmidt
866-359-1704
Manufacturer Reason
for Recall		 Product did not undergo correct sterilization procedures and may potentially be non-sterile.
FDA Determined
Cause 2		 Process control
Action Medline sent a Recall Notification Letter dated July 18, 2017 to affected via USPS 1st Class Mail. The instructions included to check inventory and quarantine affected product, complete and return the response form, arrange return of affected product, and to notify customers if the product was further distributed. For questions contact 866-359-1704.
Quantity in Commerce 5,722 units total
Distribution Worldwide Distribution - US Nationwide in the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, WA and the countries of Canada, Saudi Arabia, and Netherlands.
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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