Recall Z-0626-2013 ยท FRN Pump, Infusion
Hospira Inc.
Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
| 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 | 180 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
| K081412 | PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Hospira, Inc., Dec 17, 2008 |