PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 27, 2017 Initiated: December 1, 2017 #Z-0272-2018

Product Description

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.

Reason for Recall

3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.

Details

Units Affected
280 devices
Distribution
Distributed to Texas.
Location
Tempe, AZ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Stryker Sustainability Solutions. Units affected: 280 devices.
Why was this product recalled?
3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 27, 2017. Severity: Moderate. Recall number: Z-0272-2018.