FDAFDA · Food and drugs·Recall number Z-1704-2014
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.
Published June 11, 2014 · Recall initiated: January 24, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hospira Inc.
- Distributor
- Worldwide Distribution - USA nationwide including District of Columbia, Puerto Rico, and US Virgin Islands; Australia, Argentina, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Jordan, Kuwait, Luxembourg, Mexico, Oman, Peru, Poland, Portugal, Qatar, Russia, San Marino, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Yemen.
- Lot
- List Number: 11781; Serial Numbers: All. List Number: 11845; Serial Numbers: All. List Number: 11846; Serial Numbers: All.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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