Baxter Healthcare Corporation Recall 93503
Description: Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL
Baxter Healthcare Corporation Recall 93503 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0661-2024 |
| Event ID | 93503 |
| Event Description | Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Recall 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). |
| Device Classification | 20240117 |
| Device Code Info | All serial numbers a) ADS201844, UDI/DI 85412639598; b) ADS201845, UDI/DI 85412639604 |
| Center Classification Date | 20240105 |
| Recall Initiation Date | 20231206 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
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