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.
FDA Recall Z-0295-2018 · Posted None
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Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeFQM
Date Initiated2017-07-18
Date Terminated2020-04-24
Product Quantity5,722 units total
Reason for Recall
Product did not undergo correct sterilization procedures and may potentially be non-sterile.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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