Drug Enforcement D-1140-2023

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Status

Terminated

Classification

Class II

Report Date

September 6, 2023

Termination Date

July 16, 2024

Product Information

Product description
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Product quantity
a) 44,520; b) 60,762; c) 483,912
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-1140-2023
Event ID
92931
Recall initiation date
August 11, 2023
Center classification date
August 29, 2023
Code info
a) Lots Y403948, Exp 30-Sep-2024; Lot Y406277, Exp 31-Oct-2024. b) Lot 408790, Exp 30-Nov-2024 and c) Lots Y403740, Y403740A, Exp 30-Sep-2024; Lots Y405638, Y405805, Y407304, Y407304A Exp 31-Oct-2024; Lots Y407717, Y407717A, Y408554, Exp 30-Nov-2024; Lot Y420075, Exp 30-Apr-2025
More code info
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