HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access
FDA device recall Z-1155-2023 · posted 2023-02-22 · Open, Classified
Recall details
- Recalling firm
- Access Vascular, Inc
- Reason for recall
- Product Mislabeled on the outer bag and inner kit Tyvek header bag
- Action taken
- Access Vascular issued letter to customers on 22 DEC 2022. Letter states reason for recall, health risk and action to take: please refrain from using these kits as additional kit components may be required may cause an inconvenient in completing the procedure. AVI will provide a replacement label with the correct contents or replace the product. The following page identifies the shipments you have received with these impacted lots. Please forward this notice in the event the affected product was further distributed. We will contact you to identify the number of kits that are currently in your inventory and determine the appropriate correction with your input, in a timely manner. you have any questions about this communication, please contact us at 781-538-6594.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FOZ
- Quantity affected
- 155 units
- Distribution
- US Nationwide distribution in the states of FL, TX, WA.
- Date initiated
- 2022-12-22
- Date posted
- 2023-02-22
- Location
- Billerica, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HydroMID (K203069) | Access Vascular, Inc. | 2021-02-08 |