Z-1858-2012 Class II Terminated
FDA device recall Z-1858-2012 was initiated by Hartmann USA, Inc on May 14, 2012 and is designated Class II. Reason for recall: Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products The recall status is terminated (terminated October 6, 2014). Affected quantity: Lot 102147399 - 421 Cases; Lot 102250396 - 360 Cases; 200105390 - 522 Cases; 200206394 - 390 Cases.
Recall Details
- Product Type
- Devices
- Report Date
- July 4, 2012
- Initiation Date
- May 14, 2012
- Termination Date
- October 6, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Lot 102147399 - 421 Cases; Lot 102250396 - 360 Cases; 200105390 - 522 Cases; 200206394 - 390 Cases
Product Description
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
Reason for Recall
Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
Distribution Pattern
Nationwide distribution: USA including states of: AZ, CA, FL, GA, KY, MO, MS, NC, PA, SC, TN, TX, and VA.
Code Information
Item # 56910000 (Sterilux): 102147399, 102250396, 200105390, 200206394