| | Class 2 Recall
Plum A+ Single Channel Infusion Pumps |  |
| Date Posted |
December 07, 2012 |
| Recall Number |
Z-0481-2013 |
| Product |
Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12380; pump list number 12391, module list numbers 12097 and 12680
Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care |
| Code Information |
pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12380; pump list number 12391, module list numbers 12097 and 12680; all serial numbers
|
Recalling Firm/
Manufacturer |
Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579 |
| Consumer Instructions |
Contact the recalling firm for information |
| For Additional Information Contact |
Mr. Joseph Sener
224-212-2000
|
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.
|
| 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. |
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