Recall record at a glance
| Official record | Z-0534-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | CareFusion 303, Inc. |
| Report date | Jan 1, 2014 |
| Recall initiation date | Dec 5, 2013 |
| Quantity | 4824 total units (4242 units in US) |
| Location | San Diego, CA, United States |
Official product description
Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner.
Why the product was recalled
CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.
Distribution information
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, and Australia.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement 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.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.