ICU Medical Inc: Drug Recall

Recall #D-0062-2023 · 11/09/2022

Class II: Risk

Recall Details

Recall Number: D-0062-2023
Classification: Class II
Product Type: Drug
Recalling Firm: ICU Medical Inc
Status: Ongoing
Date Initiated: 11/09/2022
Location: Lake Forest, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 137,120 bags

Reason for Recall

Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.

Product Description

0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

Distribution Pattern

Nationwide in the USA

Other Recalls by ICU Medical Inc

Class II: Risk 12/19/2025

Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body
Class II: Risk 12/19/2025

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
Class II: Risk 12/19/2025

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
Class II: Risk 12/15/2025

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
Class II: Risk 12/15/2025

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.

View all recalls by ICU Medical Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.