CLASS II Device recall · Reported 11 Jun 2014 · FDA Enforcement Report

Plum XL, Micro Macro Plum XL3 with data port recalled by Hospira

Hospira is recalling Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port, distributed nationwide in the US. The recall was initiated on 24 Jan 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesList Number: 11555; Serial Numbers: All. List Number: 11855; Serial Numbers: All. List Number: 11859; Serial Numbers: All.

Quantity recalledList Number 11555: 17,887 pumps; List Number 11855: 1,292 pumps; List Number 11859: 147,399 pumps

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1703-2014
FDA event ID: 67453
Recalling firm: Hospira, Lake Forest, IL
Classification: Class II
Status: Terminated
Recall initiated: 24 Jan 2014
FDA classified: 3 Jun 2014
Reported: 11 Jun 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Infusion Pumps

Timeline

24 Jan 2014	Recall initiated by company
3 Jun 2014	Classified by FDA	+130 days
11 Jun 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide District of Columbia Puerto Rico

Questions about this recall

Is Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port recalled?

Yes. Hospira recalled Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port on 24 Jan 2014. The recall is Class II and its status is Terminated. Recall number Z-1703-2014.

Why was it recalled?

Which lots are affected?

List Number: 11555; Serial Numbers: All. List Number: 11855; Serial Numbers: All. List Number: 11859; Serial Numbers: All.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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30 Nov 2016Drug	CLASS II	Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira	Hospira	Sterility	Nationwide
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