Recall Z-0624-2013 ยท FRN Pump, Infusion
Hospira Inc.
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792 - Hospira MedNet Software; Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that prov
| Date | Dec 31, 2012 (initiated Dec 7, 2012) |
| Status | Terminated |
| Reason | The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump. |
| Root cause | Device Design |
| Action | Hospira Inc. sent "URGENT DEVICE FIELD CORRECTION" letters, dated December 7, 2012, to all affected customers. The letters identified the products, problem and action(s) to be taken until doors have been replaced. The customers were instructed to read the information provided carefully, including instructions to inspect the door roller assembly prior to loading a cassette for signs of damage. Customers are to complete the attached Reply Form and return it to the firm via fax at 1-877-650-8359. Customers were instructed to notify their consignees if they have further distributed the affected |
| Quantity | 297,833 units |
| Distribution | Worldwide Distribution -- USA, including Puerto Rico, and the countries of Austria, Australia, Argentina, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Finland, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, |
| 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 |
| K042081 | PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Hospira, Inc., Aug 24, 2004 |
| K070398 | HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 Hospira, Inc., Apr 24, 2007 |
| K982159 | ABBOTT PLUM A+ INFUSION PUMP Abbott Laboratories, Jan 12, 1999 |