Recall Z-0481-2013 ยท FRN Pump, Infusion
Hospira Inc.
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-l
| Date | Dec 7, 2012 (initiated Oct 26, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 t |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011442 | ABBOTT PLUM A+INFUSION PUMP, MODEL 11971 Abbott Laboratories, Jun 5, 2001 |
| K031185 | ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE Abbott Laboratories, Apr 30, 2003 |
| K052052 | HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5 Hospira, Inc., Aug 24, 2005 |
| K070398 | HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 Hospira, Inc., Apr 24, 2007 |
| K982159 | ABBOTT PLUM A+ INFUSION PUMP Abbott Laboratories, Jan 12, 1999 |