FDA recall Z-2821-2020

ARJOHUNTLEIGH POLSKA Sp. z.o.o. · Class II · device

Product

Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.

Reason for recall

Modular Junction Box (MJB) cables can melt and affect the bed functionality.

Distribution

Worldwide distribution: US (nationwide) to states of:: FL, KS, LA and countries of:: Australia, Brazil, Canada, France and Germany.

Key facts

Status
Terminated
Initiation date
2020-07-21
Report date
2020-08-26
Termination date
2021-02-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Komorniki, N/A, Poland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2821-2020