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Recall Observatory FDA recall evidence

Device 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.

Z-0295-2018

July 18, 2017

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 78360
Status
Terminated
Classification
Class II
Quantity
5,722 units total
Official record key
device-enforcement:Z-0295-2018

Official wording

Reason: Product did not undergo correct sterilization procedures and may potentially be non-sterile.

Code information: Model No. DYNJ05914, Lots: 17GB3101, 172B2025, 17FB9612, 17QB8614

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product did not undergo correct sterilization procedures and may potentially be non-sterile.