Sterile Elastic Esmark Bandage recall: Sterility Concern
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.
Why was Sterile Elastic Esmark Bandage recalled?
Product did not undergo correct sterilization procedures and may potentially be non-sterile.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No. DYNJ05914, Lots: 17GB3101, 172B2025, 17FB9612, 17QB8614
- 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.
- Recalling firm
- Medline Industries Inc
- Quantity
- 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.
- Recall date
- January 3, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)