FDA recall Z-0272-2018

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.

Reason for recall

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

Distribution

Distributed to Texas.

Key facts

Status

Terminated

Initiation date

2017-12-01

Report date

2017-12-27

Termination date

2018-09-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0272-2018