# K003616: Colleague (3CX, 3, CX) Volumetric Infusion Pump

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corp
- Decided: Dec 12, 2000 after 20 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 4, 2004 · Not classified · Z-0344-05: A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the pati
- Nov 4, 2004 · Not classified · Z-0343-05: A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the pati
- Nov 4, 2004 · Not classified · Z-0345-05: A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the pati
- Apr 13, 2004 · Not classified · Z-0880-04: Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time.
- Apr 13, 2004 · Not classified · Z-0882-04: Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time.
- Apr 13, 2004 · Not classified · Z-0881-04: Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time.

Source page: https://510kreport.com/device/K003616
Methodology: https://510kreport.com/methodology