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).
FDA Recall Z-0840-2013 · Posted 2013-02-20
Recalling FirmStryker Sustainability Solutions
Recall StatusTerminated
Product CodeJOW
Date Initiated2012-08-30
Date Terminated2014-09-30
Product Quantity1,311
Reason for Recall
Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.
Firm Action
Stryker Sustainability Solutions sent a Urgent Medical Device Removal Notification letter dated September 5, 2012, to all affected customers. The letter identified the product, problem and the action to be taken by the customer.
The firm notified that affected AC Power Adaptors would be replaced with improved Adaptors. Any affected lots would be removed and shipped back to Stryker Sustainability Solutions for final disposition.
Customers were instructed to fill out the attached Recall Effectiveness Form even if no affected product was found and fax to Stryker Sustainability Solutions at (480) 809-4957
Root Cause
Process control
Distribution Pattern
Distributed in Arizona and New Jersey.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.