FDA recall Z-2083-2020
Nelson Innovaions, Llc · Class II · device
Product
NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
Reason for recall
Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging
Distribution
CA, NC, PR
Key facts
- Status
- Ongoing
- Initiation date
- 2020-02-11
- Report date
- 2020-05-27
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Strongsville, OH, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2083-2020