FDA-Device2017-12-27Class II
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.
Stryker Sustainability Solutions
Hazard
3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.
Sold states
Distributed to Texas.
Affected count
280 devices
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0272-2018Don't want to check this manually?
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