Z-2821-2020 Class II Terminated
FDA device recall Z-2821-2020 was initiated by ARJOHUNTLEIGH POLSKA Sp. z.o.o. on July 21, 2020 and is designated Class II. Reason for recall: Modular Junction Box (MJB) cables can melt and affect the bed functionality. The recall status is terminated (terminated February 17, 2021). Affected quantity: 145 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2020
- Initiation Date
- July 21, 2020
- Termination Date
- February 17, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 145 units
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.
Distribution Pattern
Worldwide distribution: US (nationwide) to states of:: FL, KS, LA and countries of:: Australia, Brazil, Canada, France and Germany.
Code Information
Serial number range: P0597830 to P0610470 Model numbers: FXX21A4A4AKFBB, FXX21A4D3AMFBA, FXX21C4B1AAABB, FXX21C4B4ABQBA, FXX21A4C4ACGBB, FXX21A4A1ABUBA, FXX21A6C2ABPBB, FXX21C4B1AAABA, FX811B3B4AMABB, FXX21C4D4AKBBB, FX611A2B2ALVBB