device · product 1 of 5
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
- Recall number
- Z-2597-2021
- Initiated
- August 11, 2021
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- Hill-Rom, Inc.
- Quantity
- 440 units
App-derived interpretation
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.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
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.
Code information
N/A
Distribution pattern
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, DE, IL, ME, MI, MO, MS, NJ, OH, PA, VA, WA and the countries of Argentina, Australia, Austria, Bolivia, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kuwait, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates.