(1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX co
Summary
The FDA issued a Class II for (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift by Hill-Rom, Inc.. Reason: Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. There is potential that the screws are u.
Details
Source
Device Recall
External ID
Z-0783-2022
Action Date
2022-03-23
Status
Terminated
Category
device
Product Description
(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
Lot/Code Info: Distributed between 04JAN2021 and 24MAR2021. P/N Product name 3130001 Multirall 200 3301030 LikoGuard L 3301040 LikoGuard XL 3121001 Likorall 200 3122005 Likorall 242 ES natural 3122005NA Likorall 242 ES natural 3122006 Likorall 242 ES white 3122006NA Likorall 242 ES white 3122009 Likorall 242 S natural 3122009NA Likorall 242 S natural 3122010 Likorall 242 S white 3122010NA Likorall 242 S white 3122007 Likorall 242 ES R2R, natural 3122007NA Likorall 242 ES R2R, natural 3122008 Likorall 242 ES R2R, white 3122008NA Likorall 242 ES R2R, white 3122011 Likorall 242 S R2R, natural 3122011NA Likorall 242 S R2R, natural 3122012 Likorall 242 S R2R, white 3122012NA Likorall 242 S R2R, white 3123001 Likorall 243 ES, natural 3123001NA Likorall 243 ES, natural 3123002 Likorall 243 ES, white 3123002NA Likorall 243 ES, white 3122501 Likorall 250 ES, natural 3122501NA Likorall 250 ES, natural 3122502 Likorall 250 ES, white 3122502NA Likorall 250 ES, white 3124050 Likorall 250 S, IRC, natural
Quantity Affected: Traverse Rail Carrier E-System, wide 31017XX 5 Traverse Rail Carrier 31025XX 1798
Reason for Recall
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-14
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 145 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-0783-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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