Class 2 Device Recall Baxter FloRester

• Date Initiated by Firm: December 06, 2023
• Date Posted: January 05, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0656-2024
• Recall Event ID: 93503
• 510(K)Number: K883696
• Product Classification: Clamp, vascular - Product Code DXC
• Product: Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL; b) Product Code 50150: 12MM, 1.50 MM GLOBAL; c) Product Code 50175: 12MM, 1.75 MM GLOBAL; d) Product Code 50200: 12MM, 2.00 MM GLOBAL; e) Product Code 50225: 12MM, 2.25 MM GLOBAL; f) Product Code 50250: 12MM, 2.50 MM GLOBAL; g) Product Code 50275: 12MM, 2.75 MM GLOBAL; h) Product Code 50300: 12MM, 3.00 MM GLOBAL; i) Product Code 50350: 12MM, 3.50 MM GLOBAL; j) Product Code 50400: 12MM, 4.00 MM GLOBAL; k) Product Code 60100: 30MM, 1.00 MM GLOBAL; l) Product Code 60175: 30MM, 1.75 MM GLOBAL; m) Product Code 60275: 30MM, 2.75 MM GLOBAL; n) Product Code 60300: 30MM, 3.00 MM GLOBAL; o) Product Code 60350: 30MM, 3.50 MM GLOBAL; p) Product Code 50125: 12MM, 1.25 MM GLOBAL; q) Product Code 50450BIOS: 12MM, 4.50 MM GLOBAL; r) Product Code 60125BIOS: 30MM, 1.25 MM GLOBAL; s) Product Code 60150BIOS: 30MM, 1.50 MM GLOBAL; t) Product Code 60200BIOS: 30MM, 2.00 MM GLOBAL; u) Product Code 60225BIOS: 30MM, 2.25 MM GLOBAL; v) Product Code 60250BIOS: 30MM, 2.50 MM GLOBAL; w) Product Code 60400BIOS: 30MM, 4.00 MM GLOBAL; x) Product Code 60450BIOS: 30MM, 4.50 MM GLOBAL
• Code Information: a) Product Code 50100: UDI/DI 85412531908; b) Product Code 50150: UDI/DI None; c) Product Code 50175: UDI/DI None; d) Product Code 50200: UDI/DI None; e) Product Code 50225: UDI/DI None; f) Product Code 50250: UDI/DI None; g) Product Code 50275: UDI/DI None; h) Product Code 50300: UDI/DI None; i) Product Code 50350: UDI/DI None; j) Product Code 50400: UDI/DI None; k) Product Code 60100: UDI/DI None; l) Product Code 60175: UDI/DI None; m) Product Code 60275: UDI/DI None; n) Product Code 60300: UDI/DI None; o) Product Code 60350: UDI/DI None; p) Product Code 50125: UDI/DI 85412531915; q) Product Code 50450BIOS: UDI/DI 85412532011; r) Product Code 60125BIOS: UDI/DI 85412532059; s) Product Code 60150BIOS: UDI/DI 85412532066; t) Product Code 60200BIOS: UDI/DI 85412532080; u) Product Code 60225BIOS: UDI/DI 85412532097; v) Product Code 60250BIOS: UDI/DI 85412532103; w) Product Code 60400BIOS: UDI/DI 85412532141; x) Product Code 60450BIOS: UDI/DI 85412532158 All serial numbers
• 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.

• 510(K) Database: 510(K)s with Product Code = DXC