Agency classClass IIOur severity:High FDA (Devices)·Z-1857-2012·Announced 2012-07-04

Hartmann Sterile Gauze Sponges Recalled for Sterile Barrier Defects

Hartmann USA is recalling specific lots of Econolux sterile gauze sponges because micro holes were detected in the sterile barrier system, potentially compromising sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 is classified as FDA Class II. The hazard involves a potential loss of sterility in a medical device used for wound care, which presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Hartmann USA, Inc. is recalling specific lots of Hartmann Econolux sterile gauze sponges (Item # 416105). The recall affects 4"x4" 12-ply sponges used for wound cleansing, debriding, packing, covering, and swabbing. The affected lots are 101546391, 101646398, 101747392, 101850399, 101952309, and 200106397.

The recall was initiated because micro holes were detected in the laminate of the sterile barrier system of the sterilized products. This defect may compromise the sterility of the gauze sponges. The 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 the affected lots immediately. Users should check their inventory for the specific lot numbers listed above and contact Hartmann USA, Inc. for instructions on returning the products or obtaining replacements.

The recalled product

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
Manufacturer: Hartmann USA, Inc
Category: Medical Device — Wound Care
Hazard: sterility-compromise
infection-risk

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 (6)

Item # 416105 (Econolux): 101546391
101646398
101747392
101850399
101952309
200106397

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

Same hazard · sterility compromise