Device product
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
Z-1612-2023
Product summary
- Event
- Event 92138
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 50 units
- Official record key
device-enforcement:Z-1612-2023
Official wording
Reason: Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
Code information: Lot # 0000157564, UDI-DI: 00885825013585
Distribution pattern: US: WA OUS: None
Derived failure modes
-
Labeling or packaging
mislabeled