2022 SASB Index

• Twenty-one medical device product recalls that were reported to FDA and removed from the market or corrected¹
• One medical device product recall that was not reported to FDA^{1, 2}
• Seventeen medical device product recalls that were reported to non-U.S. national regulatory authorities and removed from the market or corrected

See Consistently Improve Manufacturing Capabilities and Data Summary in the Baxter 2022 Corporate Responsibility Report for information about the company’s product improvements and recall data, inclusive of drug-related recalls.

As of Dec. 31, 2022, the MedWatch Safety Alerts for Human Medical Products database included the following five Baxter medical device products:

• Baxter Issues Urgent Medical Device Correction Regarding Potential Radio Frequency Interference With Other Devices Near Beds Installed With WatchCare System
• Baxter Issues Urgent Medical Device Recall of Clearlink Solution Set 2R8403 Due to Potential Risk of Leaking Complications
• Baxter Issues Urgent Medical Device Correction Regarding Potential Risk of Medication Error When Using Abacus Order Entry and Calculation Software
• Baxter Issues Urgent Medical Device Correction to Reinforce Important Safety Information Regarding Possible Risk of Oxygen Desaturation While Using Volara Device in Line With Ventilator in a Home Care Environment
• Baxter Issues Urgent Safety Communication to Reinforce Important Safety Information Regarding Upstream Occlusion Alarms for all Spectrum V8 and Spectrum IQ Infusion Pumps

• Seven Form 483s
• Zero warning letters
• Zero seizures
• Zero consent decrees

See Consistently Improve Manufacturing Capabilities in the Baxter 2022 Corporate Responsibility Report, as well as Certain Regulatory Matters in Baxter’s 2022 Annual Report on Form 10-K for related information.

Baxter’s corporate responsibility approach prioritizes compliance with product, chemical, pharmaceutical and medical device regulations. Our global strategies and programs help ensure that we meet product materials restrictions. We use a leading third-party software tool to manage and monitor our use of chemicals. We work to avoid or minimize materials of concern as part of our EHS&S product reviews and by consulting numerous regulatory lists. Working with a third party, we collect data from suppliers to determine the use of materials of high concern. We also continue to leverage third-party testing.

See Sustainable Design and Materials Use in Products and Packaging in the Baxter 2022 Corporate Responsibility Report for information about the company's approach in this area.

Between 2020 and 2022, approximately 41% of Baxter's total facilities worldwide completed third-party audits based on ISO 13485 or ISO 9001 (including through the Medical Device Single Audit Program); approximately 44% completed ministry of health or equivalent audits (depending on location) related to manufacturing and product quality; and approximately 13% completed safety marking (such as Conformite Europeenne (CE) marking³) audits.

As of Dec. 31, 2022, approximately 30% of Baxter's Tier 1 suppliers had obtained third-party certification. There are approximately 18% of Legacy Hillrom suppliers that had obtained third-party ISO certification. 

See Consistently Improve Manufacturing Capabilities and Supplier Corporate Responsibility Audits in the Baxter 2022 Corporate Responsibility Report for related information.

• Traceability of materials from suppliers to Baxter, and throughout the manufacturing process, is maintained utilizing electronic systems.
• Products manufactured by Baxter are labeled with an identifier that is traceable from the manufacturing process to the customer and may utilize barcoding and serialization technology to facilitate electronic track-and-trace capability. Enterprise resource planning (ERP) systems are used to manage traceability to the point of sale. Baxter has business agreements with our wholesalers to ensure traceability is maintained within their distribution chains, and can be retrieved as needed.
• Baxter maintains a range of compliance-focused initiatives to help ensure all products are labeled as required by local and regional regulations to enable traceability.

See section 7.11, Product Identification and Traceability of the Baxter Supplier Quality Standard for more information.

See Baxter’s Global Interactions Policy and Ethics and Compliance in the Baxter 2022 Corporate Responsibility Report for information about the company's approach in this area.

Baxter has adopted the AdvaMed Code of Ethics and also belongs to similar industry and professional associations around the world. See Professional Codes of Ethics and Industry Standards on Baxter's Ethics and Compliance page for information.