Recall Z-0485-2018
Baxter Healthcare Corporation · initiated July 27, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
Codes / lots: Product Code 2J8003, Lot No. DR16J18096.
Reason for recall
A leak may allow for microbial contamination of the sterile fluid path.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-0485-2018
- Initiated
- July 27, 2017
- Posted by FDA
- January 11, 2018
- Terminated
- November 3, 2020
- Product code
- KPE – Container, I.V.
- Quantity
- 29,088 units
- Distribution
- Distribution in the US and Canada.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL