Recall Z-1703-2014— Hospira Inc.

Name: FDA recall Z-1703-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-24

Class II · Terminated

Class II FDA medical device recall by Hospira Inc., initiated 2014-01-24, terminated 2016-11-07. It names one FDA 510(k) clearance: K010924. Product: Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated 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.. Reason: 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.

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-01-24
Terminated: 2016-11-07
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K010924 — MODIFICATION TO PLUM XL INFUSION PUMPAbbott Laboratories·cleared 2001-04-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated 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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.