Recall Z-2083-2020 ยท NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Nelson Innovaions, Llc
NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
| Date | Feb 11, 2020 |
| Status | Open, Classified |
| Reason | Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging |
| Root cause | Process control |
| Action | Nelson Innovations, LLC contacted customers on 2/11/20 via phone call to state reason for recall, health risk and request return of affected product and provided call tags for pick-up of product. |
| Quantity | 100 units |
| Distribution | CA, NC, PR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.