D-0883-2018 Class II Terminated
FDA drug recall D-0883-2018 was initiated by ICU Medical Inc on May 31, 2018 and is designated Class II. Reason for recall: Lack of assurance of sterility: Bags have potential to leak. The recall status is terminated (terminated Jun 4, 2020). Affected quantity: 525984 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 27, 2018
- Initiation Date
- May 31, 2018
- Termination Date
- Jun 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 525984 bags
Product Description
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
Reason for Recall
Lack of assurance of sterility: Bags have potential to leak.
Distribution Pattern
Nationwide and Canada
Code Information
Lot #: 85-016-JT, Exp 01/01/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0883-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026