Allen Advance Chest Support with Pad

FDA device recall Z-2109-2023 · posted 2023-07-07 · Open, Classified

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.

Action taken

Baxter Healthcare notified customers, via USPS letter, on 05/18/2023. Customers were instructed to 1. Identify affected product and discontinue use of the old design until a replacement unit is provided. 2. Contact Baxter Order Management team to arrange the return and replacement of affected devices. 3. Acknowledge receipt of this letter by completing a reply form on the customer portal, even if there is no inventory on hand, if received directly from Baxter. 4. Please return the acknowledgement form to your distributor/wholesaler according to their instructions. 5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers and check the associated box on the customer portal reply form. Baxter initiated an expansion for additional impacted units and consignees An updated customer notification was sent to all affected customers on 06/12/2023.

Root cause

Device Design

Status

Open, Classified

Product code

GDC

Quantity affected

1,010 units

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Belgium, Croatia, Denmark, Egypt, France, I

Date initiated

2023-05-18

Date posted

2023-07-07

Location

Deerfield, IL