Recall record at a glance
| Official record | Z-0101-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | ICU Medical Inc. |
| Report date | Nov 22, 2017 |
| Recall initiation date | Oct 30, 2017 |
| Quantity | 21,461 devices |
| Location | Lake Forest, IL, United States |
Official product description
Plum 360 Infusion System, List number 30010.
Why the product was recalled
(1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled.
Distribution information
Distribution was nationwide to medical facilities. Foreign distribution was made to Canada and Australia. Government and military distribution was also made.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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