FDA-Device2012-07-04Class II
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
Hartmann USA, Inc
Hazard
Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
Sold states
Nationwide distribution: USA including states of: AZ, CA, FL, GA, KY, MO, MS, NC, PA, SC, TN, TX, and VA.
Affected count
Lot 101546391 - 200 cs; Lot 101646398 - 200 cs; 101747392 - 120 cs; Lot 101850399 - 160 cs; Lot 101952390 - 240 cs; Lot 200106397 - 200 cs
Manufactured in
481 Lakeshore Pkwy, Rock Hill, SC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1857-2012Don't want to check this manually?
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