Recall Z-1389-2018 ยท FPO Stretcher, Wheeled
Stryker Medical Division of Stryker Corporation
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working load of 870 lb (395 kg), which includes the weight of the ambulance cot, patient
| Date | May 1, 2018 (initiated Mar 12, 2018) |
| Status | Terminated |
| Reason | The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken. |
| Root cause | Nonconforming Material/Component |
| Action | On February 27, 2018, affected customers received an Urgent Medical Device Correction Notification via FedEx notifying them of the issue and potential hazard. For distributed units, the four Floor Plate Attachment Brackets that hold the anchor in place will be replaced in the field by Strykers field service personnel. Customers will be asked to return a business reply form to acknowledge that they have received and understand the notification. For further questions, please call (269) 389-8306. |
| Quantity | 4724 |
| Distribution | Worldwide Distribution - USA (nationwide) and to the countries of : Australia, Canada, France, Germany, Hong Kong, Italy, India, Netherlands, Portugal, Saint Martin, Switzerland, United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113598 | POWER-LOAD COT FASTENER SYSTEM Stryker Medical, Dec 20, 2011 |