FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
- Recall number
- Z-0485-2018
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
- Status
- Terminated
- Initiated
- 2017-07-27
- Posted
- 2018-01-11
- Terminated
- 2020-11-03
- Reason
- A leak may allow for microbial contamination of the sterile fluid path.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 29,088 units
- Distribution
- Distribution in the US and Canada.
- Lot, serial or model codes
- Product Code 2J8003, Lot No. DR16J18096.
- 510(k) numbers
- ["K964853"]
- PMA numbers
- not on file
- Product code
- KPE
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28