Recall Z-0840-2013 ยท JOW Sleeve, Limb, Compressible
Stryker Sustainability Solutions
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).
| Date | Feb 20, 2013 (initiated Aug 30, 2012) |
| Status | Terminated |
| Reason | Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit. |
| Root cause | Process control |
| 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 |
| Quantity | 1,311 |
| Distribution | Distributed in Arizona and New Jersey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090308 | RESTEP DVY SYSTEM, MODEL RSP-101 Stortford Medical, LLC, May 1, 2009 |