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