Stryker Sustainability Solutions product recalled over labeling errors

Recall date

December 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Stryker Sustainability Solutions recalls 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for u…

Recall number

Z-0272-2018

FDA classification

Class II

Brand / firm

Stryker Sustainability Solutions

Sold / distributed

Distributed to Texas.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.