PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 3, 2018 Initiated: July 18, 2017 #Z-0295-2018

Product Description

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.

Details

Recalling Firm
Medline Industries Inc
Units Affected
5,722 units total
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.
Location
Northfield, IL

Frequently Asked Questions

What product 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.. Recalled by Medline Industries Inc. Units affected: 5,722 units total.
Why was this product recalled?
Product did not undergo correct sterilization procedures and may potentially be non-sterile.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 3, 2018. Severity: Moderate. Recall number: Z-0295-2018.