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U.S. Department of Health and Human Services

Class 2 Device Recall Stick Sponge

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  Class 2 Device Recall Stick Sponge see related information
Date Initiated by Firm February 10, 2020
Create Date March 20, 2020
Recall Status1 Terminated 3 on February 13, 2023
Recall Number Z-1544-2020
Recall Event ID 85022
Product Classification Skin prep tray - Product Code OJU
Product Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.
Code Information REF DYND70288 2/PK Expiration 06/30/2022
Recalling Firm/
Manufacturer		 Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
For Additional Information Contact Benjamin Gora
866-359-1704
Manufacturer Reason
for Recall		 Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
FDA Determined
Cause 2		 Packaging
Action Medline notified customers on February 18, 2020 via "Urgent Recall Immediate Action required" letter. The consignees were instructed to complete the response form and return the product. The recall letter identified the affected product and lot numbers. Reason for the correction was also noted in the recall letter.
Quantity in Commerce 1,541,532 units
Distribution US Nationwide: MA, LA, IL, MO, MI, MN, NJ, KS, GA, NY, PA, SD, CT, TN, MD, OH, VA, FL, TX, KY, CO, IN, AL, CA, MT, OR, AK, AL, DC, IA, ME, NV, NE, SC, WV, WY, RI, NC, AZ, UT, DE and 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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