ICU Medical, Inc.: Device Recall

Recall Details

Recall Number

Z-1763-2025

Classification

Class II

Product Type

Device

Recalling Firm

ICU Medical, Inc.

Status

Ongoing

Date Initiated

05/02/2025

Location

Lake Forest, IL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

12 US, 3 OUS

Reason for Recall

Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.

Product Description

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2

Distribution Pattern

Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.

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. →