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Terminated

Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.

FDA Recall Z-1544-2020 · Posted None

Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeOJU
Date Initiated2020-02-10
Date Terminated2023-02-13
Product Quantity1,541,532 units

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.

Firm 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.

Root Cause

Packaging

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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