Infusion software recalled over concentration limits with insufficient decimal precision
ICU Medical is recalling LifeShield Drug Library Management software because Concentration Limits can only be defined to one decimal place instead of three, which may result in over- or under-delivery.
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 limits set outside manufacturer recommendations may result in over- or under-delivery, and no injuries are reported.
Plain-English summary
LifeShield Drug Library Management (DLM), part of the LifeShield Infusion Safety Software Suite v2.2, product number 17003-02, is being recalled by ICU Medical, Inc.
A 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). The firm states that 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.
The record lists 12 customers, covering the LifeShield Infusion Safety Software Suite v2.2 under UDI-DI 00887709127227. Distribution was nationwide in the United States, in California, Iowa, Kentucky, Louisiana, Maryland, Mississippi, 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 Product No. 17003-02
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
Distribution
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