High FDA (Devices)·Z-1858-2012·Announced 2012-07-04

Hartmann Sterilux Gauze Sponges Recalled for Sterile Barrier Defects

Hartmann USA is recalling Sterilux gauze sponges because micro holes were found in the sterile barrier, potentially compromising sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where the defect compromises sterility, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.

Plain-English summary

Hartmann USA, Inc. is recalling specific lots of Hartmann Sterilux sterile premium gauze sponges. The recall was initiated because micro holes were detected in the laminate of the sterile barrier system. This defect may compromise the sterility of the medical devices.

The affected product is the Hartmann Sterilux Ref 56910000 sterile premium gauze sponge, 4"x4" 12-ply. The specific lot numbers involved are 102147399, 102250396, 200105390, and 200206394. These products were distributed nationwide in the United States, including in Arizona, California, Florida, Georgia, Kentucky, Missouri, Mississippi, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia.

Healthcare facilities and consumers should stop using these specific lots of gauze sponges and contact Hartmann USA, Inc. for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this defect.

The recalled product

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
Manufacturer: Hartmann USA, Inc
Category: Medical Device — Surgical Gauze
Hazard: sterility-compromise
packaging-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

Item # 56910000 (Sterilux): 102147399
102250396
200105390
200206394

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Hartmann USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Hartmann USA, Inc

See all →

High
Hartmann Sterile Gauze Sponges Recalled for Sterile Barrier Defects
FDA (Devices) · 2012-07-04

Same hazard · sterility compromise