Recall record at a glance
| Official record | Z-0656-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Baxter Healthcare Corporation |
| Report date | Jan 17, 2024 |
| Recall initiation date | Dec 6, 2023 |
| Location | Deerfield, IL, United States |
Official 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
Why the product was recalled
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 information
US Nationwide distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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