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U.S. Department of Health and Human Services

Class 2 Device Recall Sterilux

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  Class 2 Device Recall Sterilux 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-1858-2012
Recall Event ID 61899
Product Classification Gauze/sponge,nonresorbable for external use - Product Code NAB
Product Hartmann Sterilux Ref 56910000 Sterile Premium 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 # 56910000 (Sterilux): 102147399, 102250396, 200105390, 200206394
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 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 102147399 - 421 Cases; Lot 102250396 - 360 Cases; 200105390 - 522 Cases; 200206394 - 390 Cases
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.
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