XGAUZE Trauma Dressing recall
XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed…
Why was XGAUZE Trauma Dressing recalled?
The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked adequate protective materials. If present, these small tears or pinholes may disrupt package integrity and render the device unsterile.
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?
Lot ESO54391, Expiration Date 9/25/2020; Lot ESO54725, Expiration Date 3/18/2020; Lot ESO54726, Expiration Date 3/30/2020; Lot ESO54741, Expiration Date 4/6/2020; Lot ESO54742, Expiration Date 4/13/2020; Lot ESO54743, Expiration Date 4/16/2020; Lot ESO54744, Expiration Date 4/23/2020;
- Product
- XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed…
- Recalling firm
- Revmedx Inc
- Quantity
- 5004 units
- Distribution
- US Distribution to the states of : Arizona, Idaho, North Carolina, Tennessee and Virginia.
- Recall date
- September 23, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)