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U.S. Department of Health and Human Services

Class 2 Device Recall Esmark Elastic Bandage

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 Class 2 Device Recall Esmark Elastic Bandagesee related information
Date Initiated by FirmMarch 20, 2014
Date PostedMay 21, 2014
Recall Status1 Terminated 3 on November 29, 2017
Recall NumberZ-1649-2014
Recall Event ID 67858
Product Classification Bandage, elastic - Product Code FQM
ProductEsmark 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 IL 60060-4485
For Additional Information ContactMs. 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		Employee error
ActionMedline 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 Commerce2,860 bandages
DistributionNationwide Distribution including AZ, CA, IA, IL, IN, KY, LA, MI, MS, NJ, NY, OH, PA, TX, and WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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