Recall Z-1857-2012— Hartmann USA, Inc
Class II · Terminated
Class II FDA medical device recall by Hartmann USA, Inc, initiated 2012-05-14, terminated 2014-10-06. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products.
- Recalling firm
- Hartmann USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-05-14
- Terminated
- 2014-10-06
- Firm location
- Rock Hill, SC, United States
Product description
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
Reason for recall
Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
Data sourced from openFDA. This site is unofficial and independent of the FDA.