Recall Z-2597-2021— 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: 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. 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
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
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.