Home / Recalls / Hartmann USA, Inc / Z-1858-2012

Z-1858-2012 Class II Terminated

Recalled by Hartmann USA, Inc — Rock Hill, SC

Recall Details

Product Type: Devices
Report Date: July 4, 2012
Initiation Date: May 14, 2012
Termination Date: October 6, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Lot 102147399 - 421 Cases; Lot 102250396 - 360 Cases; 200105390 - 522 Cases; 200206394 - 390 Cases

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

Reason for Recall

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

Distribution Pattern

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

Code Information

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