Class 2 Device Recall Plum XL Micro/Macro Infusion Pump

• Date Initiated by Firm: February 14, 2011
• Date Posted: March 08, 2011
• Recall Status: Terminated on November 07, 2016
• Recall Number: Z-1598-2011
• Recall Event ID: 57697
• 510(K)Number: K952799
• Product Classification: Infusion Pump - Product Code FRN
• Product: Hospira Plum XL Micro/Macro Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list number 11846
• Code Information: list number 11846, serial numbers 0012200009 through 0097830800
• Recalling Firm/ Manufacturer: Hospira Inc.; 275 N Field Dr; Lake Forest IL 60045-2579
• For Additional Information Contact: Ms. Ileana Quinones; 224-212-4892
• Manufacturer Reason for Recall: Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low audio level setting.
• FDA Determined Cause: Labeling design
• Action: Hospira sent Urgent Device Recall letters dated February 14, 2011 to their customers on the same date, informing them that Hospira had received complaints of the Plum XL, XLM and XLD infusion pumps in which the audible alarm failed. If the audible alarm fails and the user does not notice the visual alert, the user may not be aware of the change in pump status such as air-in-line or occlusion. This may result in a delay or interruption of therapy which may result in serious injury and/or death. Clinicians were instructed to weigh the risk associated with continued use of the device versus removal from service. If they elect to continue the devices, they were provided with instructions to perform alarm tests prior to each clinical use (during their pump cleaning process). If the alarm is not audible, they were instructed to discontinue use of the pump and contact Hospira Global Product Safety and Complaints at 1-800-441-4100. They were also instructed to ensure that all personnel in their facility are following Hospira's Technical Service Manual for routine decontamination of the pumps and cleaning of the buzzers during preventative maintenance, including inspection of the buzzers for leg lifting. The customers were requested to contact Hospira Advanced Knowledge Center at 1-800-241-4002 for technical assistance. The accounts were also requested to complete the attached reply form and return it to Hospira via fax at 1-866-382-4228.
• Quantity in Commerce: 23,385 pumps
• Distribution: Worldwide distribution, including United States, the U.S. Virgin Islands, Puerto Rico, Argentina, Australia, Bahamas, Bahrain, Barbados, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, EI Salvador, Finland, France, Greece, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Luxembourg, Mexico, New Zealand, Oman, Panama, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, San Marino, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom, Uruguay, United Arab Emirates and Venezuela.
• 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