• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Esmark Elastic Bandage

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Esmark Elastic Bandage
see related information
Date Posted May 21, 2014
Recall Status1 Open
Recall Number Z-1649-2014
Recall Event ID 67858
Product Classification Bandage, Elastic - Product Code FQM
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.
Code Information Product Number: DYNJ05116A . Lot Number: 13LA1009.
Recalling Firm/
Manufacturer
Medline Industries Inc
1 Medline Pl
Mundelein, Illinois 60060-4485
For Additional Information Contact Ms. Kassandra Cotner
866-359-1704
Manufacturer Reason
for Recall
This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.
FDA Determined
Cause 2
TRAINING: Employee Error
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.
Quantity in Commerce 2,860 bandages
Distribution Nationwide Distribution including AZ, CA, IA, IL, IN, KY, LA, MI, MS, NJ, NY, OH, PA, TX, and WA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-