FDA recall Z-0295-2018

Medline Industries Inc · Class II · 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.

Reason for recall

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

Distribution

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.

Key facts

Status
Terminated
Initiation date
2017-07-18
Report date
2018-01-03
Termination date
2020-04-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0295-2018