Allen Advance Chest Support with Pad
Recall
- Recall Number
- Z-2109-2023
- Event Number
- 92375
- Firm
- Baxter Healthcare Corporation
- FEI Number
- 1417572
- Product Code
- GDC
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- May 18, 2023
- Posted
- July 7, 2023
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625
Description
Allen Advance Chest Support with Pad
Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.
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.
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, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Netherlands, Norway, Poland, Qatar, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.
1,010 units