Home / Recalls / Hartmann USA, Inc / Z-1857-2012

Z-1857-2012 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 101546391 - 200 cs; Lot 101646398 - 200 cs; 101747392 - 120 cs; Lot 101850399 - 160 cs; Lot 101952390 - 240 cs; Lot 200106397 - 200 cs

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

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