Device product
NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
Z-2083-2020
Product summary
- Event
- Event 85343
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 100 units
- Official record key
device-enforcement:Z-2083-2020
Official wording
Reason: Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging
Code information: Lot #90971
Distribution pattern: CA, NC, PR
Derived failure modes
-
Foreign material or chemical contamination
Foreign material