Z-1857-2012 Class II Terminated
FDA device recall Z-1857-2012 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 101546391 - 200 cs; Lot 101646398 - 200 cs; 101747392 - 120 cs; Lot 101850399 - 160 cs; Lot 101952390 - 240 cs; Lot .
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 101546391 - 200 cs; Lot 101646398 - 200 cs; 101747392 - 120 cs; Lot 101850399 - 160 cs; Lot 101952390 - 240 cs; Lot 200106397 - 200 cs
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
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 # 416105 (Econolux): 101546391, 101646398, 101747392, 101850399, 101952309, 200106397