Status
Completed
Drug Enforcement D-0543-2023
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Classification
Class II
Report Date
May 3, 2023
Termination Date
—
Product Information
- Product description
- Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.
- Product quantity
- 9,788 bags
- Reason for recall
- Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Baxter Healthcare Corporation
- Address
-
1 Baxter Pkwy, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0543-2023
- Event ID
- 91883
- Recall initiation date
- March 15, 2023
- Center classification date
- April 24, 2023
- Code info
- Lot Y405201, Exp 31-Oct-2024
- More code info
- —