Drug Enforcement D-0431-2024

Lack of assurance of sterility: bags have the potential to leak..

Status

Terminated

Classification

Class II

Report Date

April 10, 2024

Termination Date

July 1, 2025

Product Information

Product description
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
Product quantity
7,800 bags
Reason for recall
Lack of assurance of sterility: bags have the potential to leak..
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
B. Braun Medical Inc
Address
2525 Mcgaw Ave

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0431-2024
Event ID
94272
Recall initiation date
March 22, 2024
Center classification date
April 3, 2024
Code info
Lot #: J3N023, Exp: 31 March 2026
More code info
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