FDA Recall Open, Classified

HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974

Recall: Z-0212-2024 · Initiated October 4, 2023

Recall

Recall Number
Z-0212-2024
Event Number
93161
Firm
Baxter Healthcare Corporation
FEI Number
1417572
Product Code
IOQ
Status
Open, Classified
Root Cause
Under Investigation by firm
Initiated
October 4, 2023
Posted
November 2, 2023
Address
1 Baxter Pkwy, Deerfield, IL, 60015-4625

Description

HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974

Reason

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.

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.

Distribution

US Nationwide Distribution in the states of: CA, FL, IN, MA, NY, OH, TX, VA

Quantity

499 beds