Hartmann Sterilux recall: Sterility Concern
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…
Why was Hartmann Sterilux recalled?
Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item # 56910000 (Sterilux): 102147399, 102250396, 200105390, 200206394
- 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…
- Recalling firm
- Hartmann USA, Inc
- Quantity
- Lot 102147399 - 421 Cases; Lot 102250396 - 360 Cases; 200105390 - 522 Cases; 200206394 - 390 Cases
- Distribution
- Nationwide distribution: USA including states of: AZ, CA, FL, GA, KY, MO, MS, NC, PA, SC, TN, TX, and VA.
- Recall date
- July 4, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)