Z-0965-2026Class II

LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

Name: Z-0965-2026 LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 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 List Number 17003-02 on 2025-11-24. FDA classified it as Class II and gives the reason as "For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so...". 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-0965-2026
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 List Number 17003-02
Product code: PHC Infusion Safety Management Software
Reason for recall: For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
Root cause tag: software
FDA root cause: Software Design Change
Action: Firm began notifying customers on 11/24/2025 via Urgent Medical Device Correction letters. Customers were instructed to ensure all users or potential users of LifeShield ISSS DLM 2.2.1 with Plum Duo 1.1 drug libraries are made aware of the issue and the following proposed mitigations: Until a software update is released, when performing the first Plum Duo v1.1 drug library review after the migration, the pharmacist is able to review the changes using alternate review mechanisms, as noted in the LifeShield Drug Library Management User Manual: a) Accessing the version history view of the drug library b) Review drug library reports in CSV or HTML format c) Assess each change within LifeShield DLM to verify the accuracy of the changes (i.e., view impacted medication ruleset hard dose rate limit or view a CCA to verify a maximum rate setting) The firm is developing a software update to correct the issue and will notify customers of the timing of the software update.
Quantity in commerce: 7 customers
Distribution: US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.
Product codes and lots: version 2.2.1 UDI-DI 00887709127227 Issue affects customers who migrated from LifeShield DLM v2.1x to LifeShield DLM v2.2.1 and have any version of a Plum Duo v1.1 drug library that was approved or locked for review before the migration.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0965-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0965-2026	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)