FDA Device recall Z-0660-2024
Baxter Preveleak Surgical Sealant, Product Codes: ADS201808
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of Baxter Preveleak Surgical Sealant, Product Codes: ADS201808 by Baxter Healthcare, citing 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 prod….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0660-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-06 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Baxter Preveleak Surgical Sealant, Product Codes: ADS201808
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).
Identifiers
| code_info | UDI/DI 5413765583582, All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0660-2024%22
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