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U.S. Department of Health and Human Services

Class 2 Device Recall Traverse Rail Carrier & Traverse Rail Carrier ESystem

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 Class 2 Device Recall Traverse Rail Carrier & Traverse Rail Carrier ESystemsee related information
Date Initiated by FirmJanuary 14, 2022
Create DateMarch 11, 2022
Recall Status1 Completed
Recall NumberZ-0783-2022
Recall Event ID 89562
Product Classification Lift, patient, non-ac-powered - Product Code FSA
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
Code Information 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
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
1069 State Road 46 E
Batesville IN 47006-7520
For Additional Information ContactLauren Russ
224-300-9690
Manufacturer 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
FDA Determined
Cause 2		Nonconforming Material/Component
ActionHillRom 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-conforming screws be present, these will be exchanged by an approved Hillrom technician. Action to be taken by the Distributor: Please share this Field Safety Notice with your end users and complete the attached response form and return to hillromLUL002@sedgwick.com within two weeks. Hillrom will provide replacement screws for Distributors to facilitate exchange among your end users. Action to be taken by Hillrom: Hillrom will arrange a site visit to inspect the potentially affected units. If short screws are identified, they will be exchanged with those of correct length. Contact reference person If you have any questions regarding this safety notice, please contact Hillrom Technical Support at 800-445-3720 or technical.support@hillrom.com .
Quantity in CommerceTraverse Rail Carrier E-System, wide 31017XX 5 Traverse Rail Carrier 31025XX 1798
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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