Infusion drug library software recalled over a failing change review option
ICU Medical is recalling LifeShield Drug Library Management software because the Change Summary review option stops working for migrated libraries, which may lead to dosing or setup errors.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states unreviewed library changes may lead to over delivery, under delivery or delayed pump setup, and no injuries are reported.
Plain-English summary
LifeShield Drug Library Management (DLM), part of the LifeShield Infusion Safety Software Suite v2.2, list number 17003-02, is being recalled by ICU Medical, Inc.
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, and the firm states that failure to do so may lead to over delivery, under delivery, or delay in setup on the infusion pump.
The record lists 7 customers, covering version 2.2.1 under UDI-DI 00887709127227, and notes the issue affects customers who migrated from LifeShield DLM v2.1x. Distribution was nationwide in the United States, in California, Iowa, Louisiana, New York, Pennsylvania, Tennessee and Virginia. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should follow ICU Medical's instructions.
The recalled product
- Product
- LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 7
Distribution
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