Device product
3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation and reducing wound healing time on the calf.
Z-0272-2018
Product summary
- Event
- Event 78714
- Status
- Terminated
- Classification
- Class II
- Quantity
- 280 devices
- Official record key
device-enforcement:Z-0272-2018
Official wording
Reason: 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.
Code information: Lot 6285035. UDI: 00885825016661.
Distribution pattern: Distributed to Texas.
Derived failure modes
-
Labeling or packaging
mislabeled