Revmedx Recalls XGAUZE Trauma Dressings Due to Potential Package Integrity Issues
Revmedx Inc is recalling XGAUZE Trauma Dressings because shipping containers may have caused small tears or pinholes in the packaging, potentially rendering the sterile devices unsterile.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Revmedx Inc is recalling 5,004 units of XGAUZE Trauma Dressing, catalog number FIN-0002-01. The product is a 3-inch by 36-inch z-folded rayon/polyester dressing embedded with compressed cellulose sponges that expand upon contact with blood or exudate to increase fluid absorption capacity. The dressings are packed in a pre-formed sterile barrier system and terminally sterilized via gamma radiation.
The recall was initiated because the packages may have acquired small tears or pinholes during shipping. This issue is attributed to the use of shipping containers that lacked adequate protective materials. If these tears or pinholes are present, they may disrupt the package integrity and render the device unsterile.
The affected lots are ESO54391, ESO54725, ESO54726, ESO54741, ESO54742, ESO54743, and ESO54744, with expiration dates ranging from March 18, 2020, to September 25, 2020. The products were distributed in the United States to the states of Arizona, Idaho, North Carolina, Tennessee, and Virginia. Consumers and healthcare providers should stop using the affected products and contact Revmedx Inc for further instructions.
The recalled product
- Product
- XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids.…
- Manufacturer
- Revmedx Inc
- Category
- Medical Device — Trauma Dressing
- Affected units
- 5,004
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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
Distribution
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