Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assis
FDA device recall Z-1389-2018 · posted 2018-05-01 · Terminated
Recall details
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Reason for recall
- The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FPO
- Quantity affected
- 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
- Date initiated
- 2018-03-12
- Date posted
- 2018-05-01
- Date terminated
- 2020-05-12
- Location
- Portage, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POWER-LOAD COT FASTENER SYSTEM (K113598) | Stryker Medical | 2011-12-20 |