# K002679: 6060 Multi-Therapy Pump, Model 2M9832; 6060 Epidural Pump, Model 2L9351

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corp
- Decided: Sep 18, 2000 after 21 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 11 (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 14, 2005 · Not classified · Z-0412-06: Failures within the PCA profile as well as incidents resulting in interruptions of therapy in various profiles.
- Nov 7, 2005 · Not classified · Z-0411-06: Possible shorting of some printed circuit boards could result in a possible interruption of therapy or cause the pump to fail the Power-On Self Test.
- Aug 17, 2005 · Not classified · Z-1592-05: Potential overinfusion in the Auto-Ramp mode with software versions 3.00 or higher
- Jun 13, 2005 · Not classified · Z-1088-05: There is an overinfusion condition in the Intermittent mode where the pump may continue to deliver at the higher dose rate instead of switching to the lower keep open rate once the first dose is compl
- May 4, 2005 · Not classified · Z-1086-05: The inlet and outlet lines of the administration set may be reversed, which would result in reverse flow.
- May 4, 2005 · Not classified · Z-1087-05: The inlet and outlet lines of the administration set may be reversed, which would result in reverse flow.
- Nov 19, 2004 · Not classified · Z-0386-05: A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. This can lead to free-flow of the solution and a possible ove
- Nov 19, 2004 · Not classified · Z-0385-05: A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. This can lead to free-flow of the solution and a possible ove
- Sep 1, 2004 · Not classified · Z-1570-05: The pump may free-flow if the door to the 6060 pump is not closed prior to loading the pump in to the lock box. The pump will alarm 'Door Open', but if the pump is turned off to silence the alarm whil
- Sep 1, 2004 · Not classified · Z-1569-05: The pump may free-flow if the door to the 6060 pump is not closed prior to loading the pump in to the lock box. The pump will alarm 'Door Open', but if the pump is turned off to silence the alarm whil
- Dec 17, 2003 · Not classified · Z-0376-04: Premature motor failure.

Source page: https://510kreport.com/device/K002679
Methodology: https://510kreport.com/methodology