D-0216-2019 Class II Terminated
FDA drug recall D-0216-2019 was initiated by ICU Medical Inc on Oct 8, 2018 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; bags have the potential to leak The recall status is terminated (terminated Mar 8, 2021). Affected quantity: 2,580,448 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 14, 2018
- Initiation Date
- Oct 8, 2018
- Termination Date
- Mar 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,580,448 bags
Product Description
0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045
Reason for Recall
Lack of Assurance of Sterility; bags have the potential to leak
Distribution Pattern
Nationwide.
Code Information
Lots: a) 84-011-JT Exp. December 01, 2019 and 85-014-JT Exp. January 01, 2020; b) 84-015-JT Exp. December 01, 2019; c) 84-016-JT Exp. June 01, 2019; d) 84-005-JT Exp. December 01, 2019 and 84-014-JT Exp. December 01, 2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0216-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026