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Recall Observatory FDA recall evidence

Device 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).

Z-0840-2013

August 30, 2012

Class II

Product summary

Firm
Stryker Sustainability Solutions
Event
Event 63692
Status
Terminated
Classification
Class II
Quantity
1,311
Official record key
device-enforcement:Z-0840-2013

Official wording

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

Code information: 108851407, 108851408, 108870192, 108874144, 108883271, 108886340, and 108888023.

Distribution pattern: Distributed in Arizona and New Jersey.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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