Recall Z-0912-2011 ยท KCY Tourniquet, Pneumatic
Stryker Instruments Div. of Stryker Corporation
Stryker Instruments, SmartPump Tourniquet System, Dual Channel Tourniquet Pump, REF 5920-011-000, Rx only. Intended to be used to temporarily occlude or decrease blood flow in a patient extremity during a surgical procedure of that extremity.
| Date | Jan 18, 2011 (initiated Apr 13, 2010) |
| Status | Terminated |
| Reason | This recall is related to the Electi-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time the fracture may lead to arcing inside of the molded sction of the plug and a build up of heat which can cause charring, electric shock or fire. To this date there have been zero complaint for this fa |
| Root cause | Component design/selection |
| Action | Stryker Instruments sent an Urgent - Medical Device Recall Notification letter dated April 13, 2010, to all affected customers. The letter identified the product, the problem,and the action to be taken by the customer. Stryker notified customers again on May 24, 2010, and again on September 14, 2010, via email, fax, or telephone. Customers were instructed to locate the units and visually inspect each affected cord. Remove the affected cord and dispose of it using their healthcare facilities disposal procedure. If the cord did not show signs of damage, the unit could remain in service until |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Portugal, Canada, China, Taiwan, France, Germany, Greece, Spain, India, Italy, Korea, Switzerland, Singapore, and England. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924273 | ACCUFLATE Instrumed, Inc., Jan 12, 1993 |