—#159341

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.

FDA product code: FQM — Bandage, Elastic
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: Model No. DYNJ05914, Lots: 17GB3101, 172B2025, 17FB9612, 17QB8614

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: Three Lakes Drive, Northfield, Illinois 60093

Distribution

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.

Timeline

Recall initiated: 2017-07-18
Terminated: 2020-04-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159341. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.