Device product
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
Z-1857-2012
Product summary
- Event
- Event 61899
- Status
- Terminated
- Classification
- Class II
- Quantity
- Lot 101546391 - 200 cs; Lot 101646398 - 200 cs; 101747392 - 120 cs; Lot 101850399 - 160 cs; Lot 101952390 - 240 cs; Lot 200106397 - 200 cs
- Official record key
device-enforcement:Z-1857-2012
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 # 416105 (Econolux): 101546391, 101646398, 101747392, 101850399, 101952309, 200106397
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