Medical Device: FlexoStretch Patient Lift Leveller May Lose Function During Patient Transfer
Hill-Rom's FlexoStretch Model 3156057 patient lift device may lose the ability to maintain horizontal positioning during patient transfer, risking patient falls. The FDA Class II recall affects 129 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries. The hazard describes a potential risk of patient falls if device function fails, which represents a risk-of-harm situation where injury has not yet been documented, meeting the criteria for High severity.
Plain-English summary
Hill-Rom, Inc. is recalling the FlexoStretch Model Number 3156057 patient lift device due to a potential loss of function that maintains patients in a horizontal position during lifting and patient transport.
The device may fail to maintain the correct horizontal positioning, allowing patients to slide backwards during lift operations. If this function is lost, patients could fall out of the lift sheet and back onto the surface from which they are being lifted.
The recall affects approximately 129 units of this Class II medical device, with worldwide distribution including locations throughout the United States and in multiple countries internationally.
The recalled product
- Product
- FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
- Manufacturer
- Hill-Rom, Inc.
- Affected units
- 129
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- N/A
Distribution
Part of a larger recall action
This product is one of 5 recalled by Hill-Rom, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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