Infusion pumps recalled over speakers that may not produce audible alarms
ICU Medical is recalling 423 Plum Duo Infusion Systems after one lot of defective primary speakers may fail to produce sound, so the pump may not produce audible alarms or alerts.
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 the pump may not produce audible alarms or alerts, and no injuries are reported.
Plain-English summary
The Plum Duo Infusion System, list number 40002-04-01, is being recalled by ICU Medical, Inc.
ICU Medical received one lot of defective primary speakers from its supplier that may fail to produce an audible sound. The firm states that if the primary speaker in a Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.
The record lists 423 units carrying UDI-DI M335400021, with serial numbers listed in the enforcement record. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
An infusion pump that cannot sound an alarm may leave a condition unannounced to staff. The enforcement record reports no injuries. Facilities should follow ICU Medical's instructions.
The recalled product
- Product
- Plum Duo Infusion System, List Number 40002-04-01
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion pump
- Affected units
- 423
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)
- UDI-DI: M335400021
Distribution
Distributed nationwide across the United States.
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