Class 2 Device Recall Baxter Coseal

• Date Initiated by Firm: December 06, 2023
• Date Posted: January 05, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0657-2024
• Recall Event ID: 93503
• PMA Number: P030039
• Product Classification: Sealant, polymerizing - Product Code NBE
• Product: Baxter Coseal Premix, Surgical Sealant, Product Codes:; a) 934070;; b) 934071; ; c) 934072
• Code Information: All serial numbers a) Product code 934070, UDI/DI 5413765404610; b) Product code 934071, UDI/DI 5413765404627; c) Product code 934072, have no UDI/DI.
• 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: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
• FDA Determined Cause: Under Investigation by firm
• Action: Baxter issued an IMPORTANT PRODUCT INFORMATION to its consignees on 12/06/2023 via USPS first class mail. The notice explained the issue, potential hazard involved, and requested the following: Actions to be Taken by Customers: 1. Healthcare providers may continue to safely use the products listed above while following the associated Instructions for Use. 2. Cease any further distribution of the Cardiovascular Surgery marketing brochure for the products listed above. All copies of this marketing brochure should be promptly discarded. The brochure reference number, US-AS46-220001, can be found at the bottom of the last page of the brochure. 3. If you received this communication directly from Baxter, please acknowledge receipt by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any inventory. Log in to the portal using the account number listed on the enclosed reply form instruction sheet. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. 5. If you distributed a copy of this brochure 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/reseller, or original equipment manufacturer (OEM) that distributed any copies of the brochure to other facilities, please distribute this notification to customers and check the associated box on the customer portal. For general questions, contact Baxter Healthcare Center for Service at 888-229-0001, betwe
• Distribution: US Nationwide distribution.
• 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.

• PMA Database: PMAs with Product Code = NBE and Original Applicant = BAXTER BIO SCIENCE