Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administ
FDA device recall Z-0485-2018 · posted 2018-01-11 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- A leak may allow for microbial contamination of the sterile fluid path.
- Action taken
- US consignees were notified via letter on July 27, 2017 and Canadian consignees were notified on July 31, 2017. Instructions included to locate and remove all affected product from the facility, contact Baxter Healthcare to arrange for return of product, complete and return the Reply Form, and to notify customers if the product was further distributed. For further questions, please call (800) 422-9837.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KPE
- Quantity affected
- 29,088 units
- Distribution
- Distribution in the US and Canada.
- Date initiated
- 2017-07-27
- Date posted
- 2018-01-11
- Date terminated
- 2020-11-03
- Location
- Deerfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRAVIA CONTAINER, EMPTY (K964853) | Baxter Healthcare Corp | 1997-03-31 |