6.11.14 Plum XL3 Infusion System – potential for the door roller assembly to break

Product Description Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.

Recall Number Z-1704-2014

Classification Class II

Code Info List Number: 11781; Serial Numbers: All. List Number: 11845; Serial Numbers: All. List Number: 11846; Serial Numbers: All.
Product Distributed Qty List Number 11781: 1,828 pumps; List Number 11845: 13,700 pumps; List Number 11846: 22,671 pumps

Reason For Recall There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion alarm might be triggered. Broken door roller pins can also cause the cassette door to be very loosely seated and, when jostled, may come out of position and stop infusion in the middle of therapy. And lastly, when the cassette door is opened, the cassette door mechanism may not fully clamp the IV tubing.