Hospira Plum XL3 Micro/Macro Infusion Pump, Triple Channel, with a 0.1-999 mL/hr flow rate range; list number 11845
This recall has been terminated (originally issued March 8, 2011).
- Company
- Hospira Inc.
- Recall Initiated
- February 14, 2011
- Posted
- March 8, 2011
- Terminated
- November 7, 2016
- Recall Number
- Z-1601-2011
- Quantity
- 14,186 pumps
- Firm Location
- Lake Forest, IL
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
list number 11845, serial numbers 0012100010 through 0097951146
Root Cause
Labeling design
Action Taken
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.