Hill-Rom, Inc.: Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.

Agency Publication Date: September 30, 2021

Affected Products

Product: OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Model Number: 3156056

N/A

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.

N/A

Product: Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

N/A

Product: LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

N/A

Product: LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

N/A LikoStretch Mod 600 IC, Wide 3156065B UDI: 0887761GMN000036U9

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88548

Status: Active

Manufacturer: Hill-Rom, Inc.

Manufactured In: United States

Units Affected: 5 products (440 units; 129 units; 122 units; 9 units; Undetermined)

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Sources: FDA iRES · Raw API Response

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