Z-0656-2024 Class II Ongoing
FDA device recall Z-0656-2024 was initiated by Baxter Healthcare Corporation on December 6, 2023 and is designated Class II. 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 fo… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- January 17, 2024
- Initiation Date
- December 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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
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).
Distribution Pattern
US Nationwide distribution.
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