Recall Z-1649-2014— Medline Industries Inc
Class II · Terminated
Class II FDA medical device recall by Medline Industries Inc, initiated 2014-03-20, terminated 2017-11-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient's body. It is also used as a tourniquet to restrict blood flow to a part of a patient's body.. Reason: This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile..
- Recalling firm
- Medline Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-20
- Terminated
- 2017-11-29
- Firm location
- Mundelein, IL, United States
Product description
Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient's body. It is also used as a tourniquet to restrict blood flow to a part of a patient's body.
Reason for recall
This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.
Data sourced from openFDA. This site is unofficial and independent of the FDA.