EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.
This recall has been terminated (originally issued November 16, 2022).
- Company
- Altimate Medical, Inc.
- Recall Initiated
- October 4, 2022
- Posted
- November 16, 2022
- Terminated
- August 31, 2023
- Recall Number
- Z-0243-2023
- Quantity
- 14 devices
- Firm Location
- Morton, MN
- Official Source
- View on FDA website ↗
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.
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
Root Cause
Pending
Action Taken
Altimate Medical notified consignees via email on about 10/04/2022. The email contained a letter which instructed consignees to examine unit on hand to determine if it is affected, contact Customer Service if assistance is needed determining if unit is affected, cease distribution or use of affected device, replace bracket and confirm unit is corrected and functioning properly by returning the provided verification document.