Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21

FDA device recall Z-1482-2023 · posted 2023-05-01 · Open, Classified

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).

Action taken

Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/31/2023 by US mail. The notice explained the issue and the risk and requested the following actions be taken: Identify the affected product and examine the cover for damage, if damaged, discontinue use. (undamaged device may be safely used) The mattresses will be replaced. If the product was further distributed please forward a copy of the notice. For questions, contact Baxter Technical support team at 1-800-445-3720 option 2, Monday to Friday, between the hours of 8am to 6pm EST.

Root cause

Process change control

Status

Open, Classified

Product code

IOQ

Quantity affected

5549 units

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Qatar.

Date initiated

2023-03-31

Date posted

2023-05-01

Location

Deerfield, IL