Recall Z-2762-2015 ยท NAB Gauze / Sponge,Nonresorbable For External Use
Revmedx Inc
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. XGAUZE is packed in a pre-formed sterile barrier system (pouch sealed on three sides); one side is a PET/foil/PE film, an
| Date | Sep 11, 2015 (initiated Aug 12, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Package design/selection |
| Action | RevMedx, Inc. sent the Urgent Medical Device Correction and Removal XGAUZE Trauma Dressing letter to US Customers on August 12, 2015. Customers are instructed to inspect packages for signs of damages or loss of vacuum. The affected packages will appear puffy and the dressing will be loose inside. The non-affected packages will have a good vacuum intact seal and the packaging material should contour snugly against the dressing. Customers are advised to return any packages appear to have damaged or loss of vacuum. Any undamaged packages may be used as indicated. Customers with question can |
| Quantity | 5004 units |
| Distribution | US Distribution to the states of : Arizona, Idaho, North Carolina, Tennessee and Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.