Z-1858-2012Class II

Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For...

Name: Z-1858-2012 Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For...
Creator: Hartmann USA, Inc
Published: 2012-05-14
License: https://open.fda.gov/license/

Hartmann USA, Inc / initiated 2012-05-14 / Terminated / root cause: manufacturing process

FDA source

Hartmann USA, Inc began a recall of 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... on 2012-05-14. FDA classified it as Class II and gives the reason as "Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1858-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-14
Posted: 2012-06-22
Terminated: 2014-10-06
Recalling firm: Hartmann USA, Inc
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
Product code: NAB Gauze / Sponge,Nonresorbable For External Use
Reason for recall: Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
Root cause tag: manufacturing process
FDA 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 [email protected]; 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: [email protected].
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.
Product codes and lots: Item # 56910000 (Sterilux): 102147399, 102250396, 200105390, 200206394

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1858-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1857-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-22
Z-1858-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-22

Product code NAB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)