Official recall record
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-11-24
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00887709127227
- Brand on record
- ICU Medical, Inc.
What the authority reported
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2025-11-24 · US FDA — Medical Devices
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Other recalls from this brand
- 2026-05-12 · US FDA — Medical Devices
Plum administration sets - 2026-05-12 · US FDA — Medical Devices
IV Sets with drip chambers - 2026-05-12 · US FDA — Medical Devices
IV Non-Dedicated Gravity Administration Sets with drip chambers
All 16 official recall notices naming ICU Medical, Inc. on this site →