Empty IntraVia Container with Non-DEHP Fluid Path, 500mL recallZ-0485-2018 · Baxter Healthcare Corporation · initiated Jul 27, 2017
Class II Terminated All recalls posted in January 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A leak may allow for microbial contamination of the sterile fluid path.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0485-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 27, 2017
- Posted by the FDA
- Jan 11, 2018
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 29,088 units
- Product code
- KPE
- FDA submissions
- K964853
- Distribution
- Distribution in the US and Canada.
Product description
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
Code information (models, lots, serial numbers)
Product Code 2J8003, Lot No. DR16J18096.
Other devices under the same FDA submission
7 devices cleared under K964853 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- INTRAVIA 2B8011Baxter International Inc. · CONTAINER, I.V.127 reports
- INTRAVIA 2B8012Baxter International Inc. · CONTAINER, I.V.119 reports
- INTRAVIA 2B8013Baxter International Inc. · CONTAINER, I.V.64 reports
- INTRAVIA 2B8019Baxter International Inc. · CONTAINER, I.V.45 reports
- INTRAVIA 2B8014Baxter International Inc. · CONTAINER, I.V.43 reports
- INTRAVIA 2J8002Baxter International Inc. · CONTAINER, I.V.30 reports
- INTRAVIA 2J8003Baxter International Inc. · CONTAINER, I.V.27 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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