Recall record at a glance
| Official record | Z-2879-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | CareFusion 303, Inc. |
| Report date | Oct 5, 2016 |
| Recall initiation date | Aug 8, 2016 |
| Quantity | 12,000 units |
| Location | San Diego, CA, United States |
Official product description
Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.
Why the product was recalled
A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.
Distribution information
Worldwide Distribution: US(nationwide) and countries of: Canada, Australia and United Arab Emirates.
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
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