Recall Z-0295-2018— Medline Industries Inc
Class II · Terminated
Class II FDA medical device recall by Medline Industries Inc, initiated 2017-07-18, terminated 2020-04-24. FDA's recall record names no specific 510(k) clearance for this event. 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: Product did not undergo correct sterilization procedures and may potentially be non-sterile..
- Recalling firm
- Medline Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-18
- Terminated
- 2020-04-24
- Firm location
- Northfield, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.