Recall Z-2821-2020— ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Class II · Terminated

Class II FDA medical device recall by ARJOHUNTLEIGH POLSKA Sp. z.o.o., initiated 2020-07-21, terminated 2021-02-17. FDA's recall record names no specific 510(k) clearance for this event. 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: Modular Junction Box (MJB) cables can melt and affect the bed functionality..

Recalling firm
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Classification
Class II
Status
Terminated
Initiated
2020-07-21
Terminated
2021-02-17
Firm location
Komorniki, N/A, Poland

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.