Device 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

Z-1858-2012

May 14, 2012

Class II

Product summary

Firm: Hartmann USA, Inc
Event: Event 61899
Status: Terminated
Classification: Class II
Quantity: Lot 102147399 - 421 Cases; Lot 102250396 - 360 Cases; 200105390 - 522 Cases; 200206394 - 390 Cases
Official record key: device-enforcement:Z-1858-2012

Official wording

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

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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