Recall Z-2728-2016
Hospira Inc. · initiated February 6, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Codes / lots: List number 12348, Serial Numbers: 13740156, 13740256, 13740266, 13740351, 13740380, 13740451, 13740508, 13740612, 13740632, 13740731, 13740732, 13740733, 13740734, 13740735, 13740736, 13740737, 13740738, 13740739, 13740740, 13740741, 13740742, 13740743, 13740744, 13740745, 13740746, 13740747, 13740748, 13740749, 13740750, 13740751, 13740752, 13740753, 13740754, 13740755, 13740756, 13740757, 13740758, 13740759, 13740760, 13740761, 13740762, 13740763, 13740764, 13740765, 13740766, 13740767, 13740768, 13740769, 13740770, 13740771, 13740772, 13740773, 13740774, 13740775, 13740776, 13740777, 13740778, 13740779, 13740780, 13740781, 13740782, 13740783, 13740784, 13740785, 13740786, 13740787, 13740788, 13740789, 13740790, 13740791, 13740792, 13740793, 13740794, 13740795, 13740796, 13740797, 13740798, 13740799, 13740800, 13740801, 13740802, 13740803, 13740804, 13740805, 13740806, 13740807, 13740808, 13740809, 13740810, 13740811, 13740812, 13740813, 13740814, 13740815, 13740816, 13740818, 13740819, 13740820, 13740821, 13740822, 13740823, 13740824, 13740825, 13740826, 13740827, 13740828, 13740829, 13740830, 13740831, 13740832, 13740833, 13740834, 13740835, 13740836, 13740837, 13740838…
Reason for recall
The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
FDA-determined cause: Nonconforming Material/Component
Action taken
Hospira sent an Urgent Device Field Correction letter, dated February 6, 2013, to customers. Customers were requested to return a reply form to Stericycle indicating that they have received the letter, and notified their users and/or customers. The customers were asked to supply the number of Plum A+ infusers at their facility. Product will be corrected by Hospira in the field.
Details
- Recall number
- Z-2728-2016
- Initiated
- February 6, 2013
- Posted by FDA
- September 6, 2016
- Terminated
- November 14, 2016
- Product code
- FRN – Pump, Infusion
- Quantity
- 357,778 total
- Distribution
- United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2722-2016 Class II | Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2723-2016 Class II | Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2724-2016 Class II | Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2725-2016 Class II | Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2726-2016 Class II | Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2727-2016 Class II | Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2729-2016 Class II | Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2730-2016 Class II | Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |