Hartmann USA, Inc: Medical Device Recall in 2012 - (Recall #: Z-1858-2012)

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 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 Classification:

Class II

Date Initiated: May 14, 2012

Date Posted: July 4, 2012

Recall Number: Z-1858-2012

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 102147399 - 421 Cases; Lot 102250396 - 360 Cases; 200105390 - 522 Cases; 200206394 - 390 Cases

Code Information:

Item # 56910000 (Sterilux): 102147399, 102250396, 200105390, 200206394

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