Class 2 Device Recall Allen Advance Chest Support with Pad

• Date Initiated by Firm: May 18, 2023
• Date Posted: July 07, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2109-2023
• Recall Event ID: 92375
• Product Classification: Table, operating-room, electrical - Product Code GDC
• Product: Allen Advance Chest Support with Pad
• Code Information: Product code A-71301; GTIN Number: (01)00615521003159; a. 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• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 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, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Netherlands, Norway, Poland, Qatar, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.