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Hartmann USA, Inc recalls Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For us
Recalled July 4, 2012 · FDA recall Z-1858-2012 · Hartmann USA
Hazard
Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products · FDA Class II
Units
Lot 102147399 - 421 Cases; Lot 102250396 - 360 Cases; 200105390 - 522 Cases; 200206394 - 390 Cases
Sold at
Nationwide distribution: USA including states of: AZ, CA, FL, GA, KY, MO, MS, NC, PA, SC, TN, TX, and VA.
Description
Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
Product
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
Manufacturer(s)
Hartmann USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →