Recalls / —
—#158552
Product
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
- FDA product code
- KPE — Container, I.V.
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K964853
- Affected lot / code info
- Product Code 2J8003, Lot No. DR16J18096.
Why it was recalled
A leak may allow for microbial contamination of the sterile fluid path.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Distribution pattern
- Distribution in the US and Canada.
Timeline
- Recall initiated
- 2017-07-27
- Posted by FDA
- 2018-01-11
- Terminated
- 2020-11-03
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #158552. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.