D-0655-2022 Class II Terminated
FDA drug recall D-0655-2022 was initiated by B. Braun Medical, Inc. on Feb 25, 2022 and is designated Class II. Reason for recall: Lack of sterility assurance: leaking bags The recall status is terminated (terminated Mar 16, 2023). Affected quantity: 33,742 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 23, 2022
- Initiation Date
- Feb 25, 2022
- Termination Date
- Mar 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33,742 bags
Product Description
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
Reason for Recall
Lack of sterility assurance: leaking bags
Distribution Pattern
USA Nationwide
Code Information
Lot #: J1E086, J1E204, J1E213, Exp 5/31/2023; J1H137, J1H138, Exp 6/30/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0655-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026