D-0884-2018 Class II Terminated

Recalled by ICU Medical Inc — LAKE FOREST, IL

Recall Details

Product Type
Drugs
Report Date
June 27, 2018
Initiation Date
May 31, 2018
Termination Date
June 4, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1247200 bags

Product Description

0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37

Reason for Recall

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

Distribution Pattern

Nationwide and Canada

Code Information

Lot #: 85-021-JT, Exp 01/012020; 86-001-JT, Exp 02/01/2020