Recall Z-1522-2024 ยท DXC Clamp, Vascular
Baxter Healthcare Corporation
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Rester Disposable Internal Vessel Occluder, Item Numbers: a) 50100, b) 50125, c) 50150, d) 50175, e) 50200, f) 50225, g) 50250, h) 50275, i) 50300, j) 503
| Date | Apr 12, 2024 (initiated Feb 22, 2024) |
| Status | Open, Classified |
| Reason | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU). |
| Root cause | Under Investigation by firm |
| Action | Baxter issued an IMPORTANT PRODUCT INFORMATION notice to its consignees on 02/22/2024 via USPS First Class Mail. The notice explained the issue with the marketing brochures, the potential hazards, and requested the following actions be taken: Healthcare providers may continue to safely use the Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, Vascular Probe Intravascular Probe while following the associated Instructions for Use. 2. Cease any further distribution of the Surgical Tools and Cardiovascular Specialty marketing brochures for the products listed above. A |
| Quantity | 83971 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Ireland, United Kingdom, and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942812 | FLO-RESTER DISPOSABLE VESSEL OCCLUDER Bio-Vascular, Inc., Aug 1, 1994 |