Z-1763-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2025
- Initiation Date
- May 2, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 US, 3 OUS
Product Description
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
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.
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.
Code Information
LifeShield Infusion Safety Software Suite v2.1 and v2.2 UDI-DI 00887709122802