Z-0966-2026Class II

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

Name: Z-0966-2026 LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Creator: ICU Medical, Inc.
Published: 2025-11-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2025-11-24 / Open, Classified / root cause: software

FDA source

ICU Medical, Inc. began a recall of LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02 on 2025-11-24. FDA classified it as Class II and gives the reason as "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...". 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-0966-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-24
Posted: 2025-12-19
Recalling firm: Abbott Medical
Product: LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Product code: PHC Infusion Safety Management Software
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software Design Change
Action: On November 24, 2025, the firm notified customers via Urgent Medical Device Correction letters. Consignees were asked to take the following actions: 1. Ensure all users or potential users of LifeShield DLM 2.2.1 are immediately made aware of this notification and proposed mitigations. 2. Until a software update is released, limit any newly created or edited Concentration Limits to one decimal place of precision for limits less than 100. ICU Medical is developing a software update to correct this issue and will notify customers of the timing of the software update.
Quantity in commerce: 12 customers
Distribution: US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.
Product codes and lots: LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0966-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0966-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-19

Product code PHC

K242117Class IILifeShield Infusion Safety Software SuiteIcu Medical, Inc. / cleared 2025-04-02

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)