FDA recall D-0076-2023

Product

0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862

Reason for recall

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

Distribution

FL, NJ, PA

Key facts

Status

Terminated

Initiation date

2022-11-25

Report date

2022-12-14

Termination date

2024-08-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0076-2023