Home / Recalls / Hospira Inc. / Z-0626-2013

Z-0626-2013 Class II Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA device recall Z-0626-2013 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: 180 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: 180 units

Product Description

Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.

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 number 11005; 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-0626-2013
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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