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Z-0840-2013 Class II Terminated

Recalled by Stryker Sustainability Solutions — Tempe, AZ

FDA device recall Z-0840-2013 was initiated by Stryker Sustainability Solutions on Aug 30, 2012 and is designated Class II. Reason for recall: Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit. The recall status is terminated (terminated Sep 30, 2014). Affected quantity: 1,311.

Recall Details

Product Type: Devices
Report Date: Feb 27, 2013
Initiation Date: Aug 30, 2012
Termination Date: Sep 30, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,311

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.

Distribution Pattern

Distributed in Arizona and New Jersey.

Code Information

108851407, 108851408, 108870192, 108874144, 108883271, 108886340, and 108888023.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0840-2013
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.