Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hos
FDA device recall Z-1864-2012 · posted 2012-06-22 · Terminated
Recall details
- Recalling firm
- Hill-Rom, Inc.
- Reason for recall
- During an evaluation of Advanta 2 siderail samples returned from the field it was found that the screws used to attach the siderail were being stripped from the plastic cavity of the siderail.
- Action taken
- Hill-Rom sent an "URGENT FIELD SAFETY NOTICE" dated May 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included a Customer Response Form for customers to complete and return to the firm. Contact Hill-Rom Technical Support at 800-445-3720 for questions regarding this notice.
- Root cause
- Process design
- Status
- Terminated
- Product code
- FNL
- Quantity affected
- 7843 devices
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, France, and Singapore.
- Date initiated
- 2012-06-18
- Date posted
- 2012-06-22
- Date terminated
- 2014-06-06
- Location
- Batesville, IN
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