Recall Z-0783-2022— Hill-Rom, Inc.

Class II FDA medical device recall by Hill-Rom, Inc., initiated 2022-01-14, terminated 2024-11-07. FDA's recall record names no specific 510(k) clearance for this event. Product: (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 3102519 TR CARR. LOW.LR 30MM/PAIR 3102511 TR CARRIER NORMAL, LR 3102531 TRAVERSE RL CARRIER STD/RAISED 3102512 TR CARRIER WIDE, LR 3102532 TRAVERSE RL CARRIER WD/RAISED 3102513 TR CARRIER SLIM, LR 3102562 TR CARRIER, PARALLEL/WIDE. 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.

Recalling firm

Hill-Rom, Inc.

Classification

Class II

Status

Terminated

Initiated

2022-01-14

Terminated

2024-11-07

Firm location

Batesville, IN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.