Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0212-2024Class II

HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033...

Baxter Healthcare Corporation / initiated 2023-10-04 / Open, Classified

Baxter Healthcare Corporation began a recall of HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054... on . FDA classified it as Class II and gives the reason as "Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator through the transport handle during transport, resulting in a mild...". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-0212-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Baxter Healthcare Corporation
Product
HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974
Product code
IOQ Bed, Flotation Therapy, Powered
Reason for recall
Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator through the transport handle during transport, resulting in a mild static electric shock.
FDA root cause
Under Investigation by firm
Action
Baxter issued an Urgent Medical Device Correction notice to its consignees on 10/04/2023 by USPS first class mail. The notice explained the potential problem and hazard. Baxter will be correcting this issue by installing a conductive drag chain on the Progressa+ bed frame to prevent the electrostatic charge buildup. A Baxter representative will contact your facility to schedule a device correction to add the conductive drag chain. Please note you will be receiving this correction from Baxter at no charge. All units purchased in the future will have the drag chain.
Quantity in commerce
499 beds
Distribution
US Nationwide Distribution in the states of: CA, FL, IN, MA, NY, OH, TX, VA
Product codes and lots
UDI/DI 00887761966925, all serial numbers

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0212-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0212-2024Class IIOngoingVoluntary: Firm initiated