Recall Z-0840-2013— Stryker Sustainability Solutions

Name: FDA recall Z-0840-2013
Creator: U.S. Food and Drug Administration
Published: 2012-08-30

Class II · Terminated

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2012-08-30, terminated 2014-09-30. It names one FDA 510(k) clearance: K090308. Product: STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 (AC Power Adaptor).. Reason: Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit..

Recalling firm: Stryker Sustainability Solutions
Classification: Class II
Status: Terminated
Initiated: 2012-08-30
Terminated: 2014-09-30
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K090308 — RESTEP DVY SYSTEM, MODEL RSP-101Stortford Medical, LLC·cleared 2009-05-01

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

STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 (AC Power Adaptor).

Reason for recall

Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.

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