Recall Z-0272-2018— Stryker Sustainability Solutions

Name: FDA recall Z-0272-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-01

Class II · Terminated

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2017-12-01, terminated 2018-09-27. It names one FDA 510(k) clearance: K012403. 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: 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves..

Recalling firm: Stryker Sustainability Solutions
Classification: Class II
Status: Terminated
Initiated: 2017-12-01
Terminated: 2018-09-27
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K012403 — VANGUARD REPROCESSED COMPRESSION GARMENTVanguard Medical Concepts, Inc.·cleared 2001-10-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.