FDA Recall Terminated

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.

Recall: Z-1649-2014 · Initiated March 20, 2014

Recall

Recall Number
Z-1649-2014
Event Number
67858
Firm
Medline Industries Inc
FEI Number
1417592
Product Code
FQM
Status
Terminated
Root Cause
Employee error
Initiated
March 20, 2014
Posted
May 21, 2014
Terminated
November 29, 2017
Address
1 Medline Pl, Mundelein, IL, 60060-4485

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

This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.

Action

Medline Industries issued an Immediate Action Required letter dated March 20, 2014 to all affected customers. The letters included instructions to: 1) immediately check inventories for the recalled products and quarantine the recalled products; 2) complete and return the enclosed destruction form listing the quantity of destroyed product (credit will only be issued if the completed form is received); and 3) If the customer is a distributor, promptly notify the distributor's customers that may have received the recalled products about this recall. Direct accounts and their customers that have any questions can contact Medline Industries at 866-359-1704.

Distribution

Nationwide Distribution including AZ, CA, IA, IL, IN, KY, LA, MI, MS, NJ, NY, OH, PA, TX, and WA.

Quantity

2,860 bandages