Z-1763-2025Class II

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

Name: Z-1763-2025 LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Creator: ICU Medical, Inc.
Published: 2025-05-02
License: https://open.fda.gov/license/

Abbott Medical / initiated 2025-05-02 / Open, Classified / root cause: software

FDA source

ICU Medical, Inc. began a recall of LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2 on 2025-05-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1763-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-02
Posted: 2025-05-14
Recalling firm: Abbott Medical
Product: LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Product code: PHC Infusion Safety Management Software
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.
Root cause tag: software
FDA root cause: Software Design Change
Action: Firm began notifying consignees on May 2, 2025 via hand delivery of letters titled "Urgent Medical Device Correction." Issue 1: User receives an error if they attempt to define a Percentage Dose Change Increase limit between 60% and 99%. Customers were instructed to ensure all users or potential users of the software are made aware of the notification and proposed mitigations: Use Percentage Dose Change Increase values between 20% and 59% or between 100% and 500%. Pharmacists will not be able to use values from 60% to 99%. Issue 2: It is possible for an unauthorized user to bypass the reauthentication steps required to approve a drug library or delete a medication ruleset. Customers were instructed to ensure all users or potential users are made aware of the notification and proposed mitigation: Communicate with all users the need to log off after finishing a session before leaving the workstation and following cybersecurity best practices. ICU Medical is developing a LifeShield software update to correct both issues.
Quantity in commerce: 12 US, 3 OUS
Distribution: Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.
Product codes and lots: LifeShield Infusion Safety Software Suite v2.1 and v2.2 UDI-DI 00887709122802

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1763-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1763-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-14

Product code PHC

K223606Class IILifeShield™ Infusion Safety Software SuiteIcu Medical, Inc. / cleared 2023-08-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)