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U.S. Department of Health and Human Services

Class 2 Device Recall Plum XL

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 Class 2 Recall
Plum XL
see related information
Date Posted June 03, 2014
Recall Status1 Open
Recall Number Z-1704-2014
Recall Event ID 67453
Premarket Notification
510(K) Number
K952799 
Product Classification Pump, Infusion - Product Code FRN
Product Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.
Code Information List Number: 11781; Serial Numbers: All. List Number: 11845; Serial Numbers: All. List Number: 11846; Serial Numbers: All.
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579
For Additional Information Contact Hospira Global Complaint Management
224-212-2000
Manufacturer Reason
for Recall
There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Hospira sent an URGENT MEDICAL DEVICE RECALL letter dated January 24, 2014, to all affected customers via traceable UPS. The letters included instructions for recipients to: inspect the door roller assemblies; if a door roller or pin appears loose, broken or missing, remove the device from clinical service until the door assembly is replaced with a corrected door assembly and contact Hospira at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) to report the issue. All devices requiring repair will be serviced and replaced with the existing design door and/or pin. Hospira is in the process of designing a metal door roller pin to replace the plastic on currently available on the Plum XL and once that design is complete, any door roller/pin serviced on a Plum XL will be replaced with the new metal design. Recipients are further instructed to: inform potential users in their organization of the recall notification; complete the attached reply form and return it to the fax number or e-mail address on the form; and if the pumps were further distributed, to notify the accounts that received the devices and ask them to contact Stericycle at 877-597-9581 (Monday - Friday, 8:00 AM - 5:00 PM EST) to receive a reply form. The URGENT MEDICAL DEVICE RECALL letter also reports that Hospira is in the process of retiring the Plum LifeCare 5000 and Plum XL families of infusion devices as noted in the IMPORTANT PLUM INFUSION PUMP DISCONTINUATION AND TRANSITION NOTICE issued May 1, 2013. As of June 30, 2015, Hospira will consider the products within the Plum LifeCare 5000 and Plum XL Infusion Systems families retired and will no longer support them. For questions regarding this recall call 224-212-2000.
Quantity in Commerce List Number 11781: 1,828 pumps; List Number 11845: 13,700 pumps; List Number 11846: 22,671 pumps
Distribution Worldwide Distribution - USA nationwide including District of Columbia, Puerto Rico, and US Virgin Islands; Australia, Argentina, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Jordan, Kuwait, Luxembourg, Mexico, Oman, Peru, Poland, Portugal, Qatar, Russia, San Marino, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Yemen.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = ABBOTT LABORATORIES
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