Multi-event October 2018 FDA Recall Drug by Icu Medical Inc
This Multi-event Class II drug recall was voluntarily initiated by Icu Medical Inc on October 8, 2018 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; bags have the potential to leak. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0215-2019
Lack of Assurance of Sterility; bags have the potential to leak
10-08-2018
11-14-2018
372,912 bags
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
ICU Medical Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
03-08-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
Batch or Lot Expiration Information
Lot# Lots: a) 84-017-JT Exp. December 01, 2019; b) 84-012-JT Exp. June 01, 2019
Recall Number: D-0216-2019
Lack of Assurance of Sterility; bags have the potential to leak
10-08-2018
11-14-2018
2,580,448 bags
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
ICU Medical Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
03-08-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# 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
