Home / Recalls / Hospira Inc. / Z-0481-2013

Z-0481-2013 Class II Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA device recall Z-0481-2013 was initiated by Hospira Inc. on Oct 26, 2012 and is designated Class II. Reason for recall: The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may… The recall status is terminated (terminated Nov 14, 2016).

Recall Details

Product Type: Devices
Report Date: Dec 19, 2012
Initiation Date: Oct 26, 2012
Termination Date: Nov 14, 2016
Voluntary/Mandated: Voluntary: Firm initiated

Product Description

Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12380; pump list number 12391, module list numbers 12097 and 12680 Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump 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 volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.

Distribution Pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico, and the countries of Australia, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Lavenia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates and Vietnam.

Code Information

pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12380; pump list number 12391, module list numbers 12097 and 12680; 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-0481-2013
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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