The Recall Desk
HighFDA (Devices)·Z-0783-2022·Announced 2022-03-23

Traverse Rail Carrier E-System components with defective short screws

Hill-Rom Traverse Rail Carrier E-System components contain non-conforming screws that are too short to secure the rail properly. The screws could loosen over time, causing the rail system to fall and potentially injure caregivers or patients.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA medical device recall involving a structural defect with potential risk of fall-related injury. The source text reports no actual illnesses or injuries; the harm is theoretical. Per the rubric, risk-of-harm products without reported injury score at most 3.

Plain-English summary

Hill-Rom, Inc. is recalling Traverse Rail Carrier E-System and Traverse Rail Carrier components, which are parts of Liko overhead lift systems used in healthcare settings for patient handling and mobility assistance.

The recall is due to non-conforming screws supplied with the devices that are too short to ensure proper installation. The screws may be unable to secure the traverse rail appropriately and could loosen over time, potentially causing the rail system to fall. This poses a risk of injury to caregivers and patients.

The affected components were distributed worldwide between January 4, 2021 and March 24, 2021, including to facilities throughout the United States and to Austria, Canada, Czech Republic, Denmark, Spain, Finland, France, Great Britain, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Norway, New Zealand, Russia, Sweden, Singapore, and Slovakia.

The recalled product

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 C
Manufacturer
Hill-Rom, Inc.
Category
Medical Device — Patient lift component
Hazard
  • loose-fasteners
  • fall-hazard
  • mechanical-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

  • 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

Distribution

Distributed nationwide across the United States.

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