Recall record at a glance
| Official record | Z-1567-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | CareFusion 303, Inc. |
| Report date | May 21, 2014 |
| Recall initiation date | Apr 23, 2014 |
| Quantity | 57,219 units total (55,756 units in US) |
| Location | San Diego, CA, United States |
Official product description
Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.
Why the product was recalled
CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used.
Distribution information
Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AU, and KW.
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.
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