Recall StatusTerminated
Date Initiated2022-01-14
Date Terminated2024-11-07
Product QuantityTraverse 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
Firm 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-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
[email protected] 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
[email protected] .
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.