Z-0626-2013Class II

Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005

Name: Z-0626-2013 Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005
Creator: Hospira Inc.
Published: 2012-12-07
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-12-07 / Terminated / root cause: design

FDA source

Hospira Inc. began a recall of Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System... on 2012-12-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0626-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-07
Posted: 2012-12-31
Terminated: 2016-11-14
Recalling firm: Abbott Medical
Product: 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.
Product code: FRN Pump, Infusion
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.
Root cause tag: design
FDA root cause: Device Design
Action: Hospira Inc. sent "URGENT DEVICE FIELD CORRECTION" letters, dated December 7, 2012, to all affected customers. The letters identified the products, problem and action(s) to be taken until doors have been replaced. The customers were instructed to read the information provided carefully, including instructions to inspect the door roller assembly prior to loading a cassette for signs of damage. Customers are to complete the attached Reply Form and return it to the firm via fax at 1-877-650-8359. Customers were instructed to notify their consignees if they have further distributed the affected product. If customers require additional assistance, they are to contact Stericycle at 1-877-650-0362..
Quantity in commerce: 180 units
Distribution: 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.
Product codes and lots: list number 11005; all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0626-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0624-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-09	2012-12-31
Z-0625-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-09	2012-12-31
Z-0626-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-09	2012-12-31

Product code FRN

K081412Class IIPlum a+ Hyperbaric Infusion System with Hospira Mednet SoftwareHospira, Inc. / cleared 2008-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)