Recall Z-0783-2022 ยท FSA Lift, Patient, Non-Ac-Powered
Hill-Rom, Inc.
(1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR ESYST WIDE 3102517 TR CARR. NORMAL/LOWER. LR 3102506 TR CARRIER WIDE/RAISED ML
| Date | Jan 14, 2022 |
| Status | Terminated |
| Reason | Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. There is potential that the screws are unable to secure the traverse rail appropriately and could loosen over time causing the rail system to fall, potentially causing injury to caregivers and/or patients |
| Root cause | Nonconforming Material/Component |
| Action | HillRom issued Urgent Medical Device Correction letter(FA-2021-11-004-LUL-002) on the 14th of January via UPS Ground service. Letter states reason for recall, health risk and action to take: Actions to be taken by Customer: Please identify if you have the potentially affected product in your facility (See affected device listing above). Do not use your traverse carrier until inspected by a Hillrom Technician. Return the response form below within two weeks. Upon receipt of the response form, Hillrom will contact you to schedule a visit to inspect your carriers. Should incorrect, non-conformi |
| Quantity | Traverse Rail Carrier E-System, wide 31017XX 5 Traverse Rail Carrier 31025XX 1798 |
| Distribution | Worldwide distribution - US Nationwide and the countries of AT, CA, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IT, JP, NL, NO, NZ, RU, SE, SG, SK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.