Recall Z-0295-2018 ยท FQM Bandage, Elastic
Medline Industries Inc
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.
| Date | Jul 18, 2017 |
| Status | Terminated |
| Reason | Product did not undergo correct sterilization procedures and may potentially be non-sterile. |
| Root cause | Process control |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.