Home / Recalls / Hospira Inc. / Z-0625-2013

Z-0625-2013 Class II Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA device recall Z-0625-2013 was initiated by Hospira Inc. on Dec 7, 2012 and is designated Class II. Reason for recall: The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV… The recall status is terminated (terminated Nov 14, 2016). Affected quantity: 28,599 units.

Recall Details

Product Type: Devices
Report Date: Jan 9, 2013
Initiation Date: Dec 7, 2012
Termination Date: Nov 14, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 28,599 units

Product Description

Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care

Reason for Recall

The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.

Distribution Pattern

Worldwide Distribution -- USA, including Puerto Rico, and the countries of Austria, Australia, Argentina, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Finland, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates, and Vietnam.

Code Information

list numbers 12348, 12618, and 20678; all serial numbers

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0625-2013
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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