Hartmann USA, Inc: Medical Device Recall in 2012 - (Recall #: Z-1857-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 14, 2012

Date Posted: July 4, 2012

Recall Number: Z-1857-2012

Event ID: 61899

Reason for Recall:

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

Status: Terminated

Product Quantity: Lot 101546391 - 200 cs; Lot 101646398 - 200 cs; 101747392 - 120 cs; Lot 101850399 - 160 cs; Lot 101952390 - 240 cs; Lot 200106397 - 200 cs

Code Information:

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

Distribution Pattern:

Nationwide distribution: USA including states of: AZ, CA, FL, GA, KY, MO, MS, NC, PA, SC, TN, TX, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated