Sterile Elastic Esmark Bandage recalled over sterility concerns

Recall date

July 18, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Medline Industries Inc recalls Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into…

Recall number

Z-0295-2018

FDA classification

Class II

Brand / firm

Medline Industries Inc

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.