Recall Z-0656-2024 ยท DXC Clamp, Vascular
Baxter Healthcare Corporation
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:
| Date | Jan 5, 2024 (initiated Dec 6, 2023) |
| Status | Open, Classified |
| Reason | 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). |
| Root 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 fou |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883696 | FLO-RESTER Bio-Vascular, Inc., Nov 30, 1988 |