Reported Jul 4, 2012 · Terminated

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

Hartmann USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hartmann USA, Inc · 481 Lakeshore Pkwy · Rock Hill, SC · 29730-4205

Is this the product you have?

  • 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
Lot codes and dates
    • Item # 56910000 (Sterilux): 102147399
    • 102250396
    • 200105390
    • 200206394
Amount recalled
Lot 102147399 - 421 Cases; Lot 102250396 - 360 Cases; 200105390 - 522 Cases; 200206394 - 390 Cases

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 6, 2014 · Data as of Sep 19, 5:25 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.