FDA Medical Device Recalls (openFDA)
Hartmann USA, Inc: 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
- Recall number
- Z-1857-2012
- Recalling firm
- Hartmann USA, Inc
- 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
- Status
- Terminated
- Initiated
- 2012-05-14
- Posted
- 2012-06-22
- Terminated
- 2014-10-06
- Reason
- Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
- Root 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
- 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.
- Lot, serial or model codes
- Item # 416105 (Econolux): 101546391, 101646398, 101747392, 101850399, 101952309, 200106397
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAB
- Firm FEI
- 1218946
- Firm city
- Rock Hill
- Firm state
- SC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28