Recall Z-2730-2016
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 with Hospira MedNet Software. List Number 20678. 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 20678. Serial numbers: 15541001, 15541011, 15541021, 15541031, 15541041, 15541051, 15541061, 15541071, 15541081, 15541091, 15541101, 15541111, 15541121, 15541131, 15541141, 15541151, 15541161, 15541171, 15541181, 15541191, 15541201, 15541211, 15541231, 15541241, 15541261, 15541271, 15541281, 15541291, 15541301, 15541311, 15541321, 15541331, 15541341, 15541351, 15541361, 15541371, 15541381, 15541391, 15541401, 15541411, 15541421, 15541431, 15541441, 15541451, 15541461, 15541471, 15541481, 15541491, 15541501, 15541511, 15541521, 15541531, 15541541, 15541551, 15541561, 15541571, 15541581, 15541591, 15541601, 15541611, 15541621, 15541631, 15541641, 15541651, 15541661, 15541671, 15541681, 15541691, 15541701, 15541711, 15541721, 15541731, 15541741, 15541751, 15541761, 15541771, 15541781, 15541791, 15541801, 15541811, 15541821, 15541831, 15541841, 15541851, 15541861, 15541871, 15541881, 15541891, 15541901, 15541911, 15541921, 15541931, 15541941, 15541951, 15541961, 15541971, 15541981, 15541991, 15542001, 15542011, 15542021, 15542031, 15542041, 15542051, 15542061, 15542071, 15542081, 15542091, 15542101, 15542111, 15542121, 15542131, 15542141, 15542151, 15542161, 15542171…
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-2730-2016
- 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-2728-2016 Class II | Plum A+3 Infusion Pump System. List Number 12348. 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-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 |