EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing
Summary
The FDA issued a Class II for EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. U by Altimate Medical, Inc.. Reason: Some EasyStand Bantam Small and Extra Small standers with the non-supine option may have been manufactured with a component that affects the operation.
Details
Source
Device Recall
External ID
Z-0243-2023
Action Date
2022-11-23
Status
Terminated
Category
device
Product Description
EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.
Lot/Code Info: a. UDI: (01)10858921006062(21)V2005693010, (01)10858921006062(21)V2005693012, (01)10858921006062(21)V2005693015, (01)10858921006062(21)V2005693017, (01)10858921006062(21)V2005694003, (01)10858921006062(21)V2005694009, (01)10858921006062(21)V2005694020, (01)10858921006062(21)V2005695010, (01)10858921006062(21)V2005695011, (01)10858921006062(21)V2005695018, (01)10858921006062(21)V2005695019, (01)10858921006062(21)V2005695020; b. UDI: (01)10858921006079(21)V1005700003, (01)10858921006079(21)V1005700009
Quantity Affected: 14 devices
Reason for Recall
Some EasyStand Bantam Small and Extra Small standers with the non-supine option may have been manufactured with a component that affects the operation of the leg assembly bracket to maintain the standers non-supine position.
Distribution
Worldwide - US distribution in the states of CA, CT, FL, LA, MI, TN, TX and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-04
Company
Morton, MN
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 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Altimate Medical, Inc. has 2 FDA actions in our database, including 2 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 (Altimate Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Altimate Medical, Inc. have FDA actions?
Altimate Medical, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0243-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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