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U.S. Department of Health and Human Services

Class 2 Device Recall Econolux

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  Class 2 Device Recall Econolux see related information
Date Initiated by Firm May 14, 2012
Date Posted June 22, 2012
Recall Status1 Terminated 3 on October 06, 2014
Recall Number Z-1857-2012
Recall Event ID 61899
Product Classification Gauze/sponge,nonresorbable for external use - Product Code NAB
Product Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges

For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing
Code Information Item # 416105 (Econolux): 101546391, 101646398, 101747392, 101850399, 101952309, 200106397
Recalling Firm/
Hartmann USA, Inc
481 Lakeshore Pkwy
Rock Hill SC 29730-4205
For Additional Information Contact
Manufacturer Reason
for Recall
Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
FDA Determined
Cause 2
Material/Component Contamination
Action The firm, HARTMANN USA, sent an "URGENT: RECALL NOTICE" dated May 14, 2012 to its Consignees/Customers. The notice described the product, problem and actions to be taken. The customers were instructed to examine their inventory, block further shipments of affected items and retrieve additional affected stock from their customers; to confirm initial receipt of the notice by emailing recall@harmanninfo.com; complete and return the Affected Products and Stock Levels form via fax to: HARTMANN USA customer service at (1-803-325-7606); contact customer service to obtain a Returned Goods Authorization; and take adequate measures to ensure this notice is distributed appropriately. If you have any further questions or issues related to this recall, please contact HARTMANN USA customer service or your sales representative at 1-800-243-2294 or email: recall@hartmanninfo.com.
Quantity in Commerce Lot 101546391 - 200 cs; Lot 101646398 - 200 cs; 101747392 - 120 cs; Lot 101850399 - 160 cs; Lot 101952390 - 240 cs; Lot 200106397 - 200 cs
Distribution Nationwide distribution: USA including states of: AZ, CA, FL, GA, KY, MO, MS, NC, PA, SC, TN, TX, and VA.
Total Product Life Cycle TPLC 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.