Class 2 Device Recall Econolux

• Date Initiated by Firm: May 14, 2012
• Date Posted: June 22, 2012
• Recall Status: Terminated 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/ Manufacturer: Hartmann USA, Inc; 481 Lakeshore Pkwy; Rock Hill SC 29730-4205
• For Additional Information Contact: 803-325-7600
• 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: 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.