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U.S. Department of Health and Human Services

Class 2 Device Recall Plum A Hyperbaric Single Channel Infusion Pumps

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  Class 2 Device Recall Plum A Hyperbaric Single Channel Infusion Pumps see related information
Date Initiated by Firm October 26, 2012
Date Posted December 07, 2012
Recall Status1 Terminated 3 on November 14, 2016
Recall Number Z-0482-2013
Recall Event ID 63518
510(K)Number K081412  
Product Classification Pump, infusion - Product Code FRN
Product Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc., Lake Forest, IL 60045; pump list number 11005, module list number 11006

Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
Code Information pump list number 11005 and module list number 11006; all serial numbers  
Recalling Firm/
Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information Contact Mr. Joseph Sener
Manufacturer 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.
FDA Determined
Cause 2
Device Design
Action The firm, Hospira Inc. sent "URGENT DEVICE FIELD CORRECTION" letters dated October 26, 2012 to all affected customers. The letters identified the products, problem and action(s) to be taken. The customers were instructed to read the information provided carefully, complete the attached Reply Form and return it to the firm via fax at 1-877-650-8667. The letter states that the System Operating Manual will be updated to clarify the instructions for setting the volume, and that the updated manuals will be sent as soon as they are available. Customers were instructed to notify their consignees if they have further distributed the affected product. The customers were requested to contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, for additional information and technical assistance.
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = HOSPIRA, INC.