Recall Z-2601-2021— Hill-Rom, Inc.

Class II · Ongoing

Class II FDA medical device recall by Hill-Rom, Inc., initiated 2021-08-11. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm
Hill-Rom, Inc.
Classification
Class II
Status
Ongoing
Initiated
2021-08-11
Firm location
Batesville, IN, United States

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.