Baxter Flo-Rester Vessel Occluder Recall Due to Inaccurate Marketing Brochure
Baxter Healthcare is recalling Flo-Rester internal vessel occluders because marketing materials contain inaccurate information that doesn't match the product's Instructions for Use and Prescribing Information.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a documentation discrepancy with no reported illnesses, injuries, or hospitalizations. The issue is a labeling/documentation error—inaccurate marketing materials versus actual product instructions—classified as a minor labeling issue.
Plain-English summary
Baxter Healthcare Corporation is recalling Baxter Flo-Rester Disposable internal vessel occluders due to inaccurate content in a cardiovascular surgery marketing brochure (US-AS46-220001). The brochure distributed for the product contains information that does not align with the product's Instructions for Use (IFU) or Prescribing Information (PI).
The discrepancy between marketing materials and the actual product documentation could lead to confusion among healthcare providers regarding proper product use and specifications.
The recalled occluders were distributed nationwide in the United States. The products are available in multiple sizes with product codes ranging from 50100 to 60450BIOS. Affected healthcare facilities and providers should verify they have the correct Instructions for Use and Prescribing Information, and reference only the official IFU/PI rather than the marketing brochure for guidance on product use.
The recalled product
- 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…
- Manufacturer
- Baxter Healthcare Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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