FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the cente
Summary
The FDA issued a Class II for FlexoStretch Model Number: 3156057 - The combination of this products allows the by Hill-Rom, Inc.. 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 fun.
Details
Source
Device Recall
External ID
Z-2598-2021
Action Date
2021-10-06
Status
Ongoing
Category
device
Product Description
FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
Lot/Code Info: N/A
Quantity Affected: 129 units
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.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-11
Company
Batesville, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hill-Rom, Inc. has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hill-Rom, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hill-Rom, Inc. have FDA actions?
Hill-Rom, Inc. has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2598-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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