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Open, Classified

Allen Advance Chest Support with Pad

FDA Recall Z-2109-2023 · Posted 2023-07-07

Recall StatusOpen, Classified
Product CodeGDC
Date Initiated2023-05-18
Product Quantity1,010 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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