Recall Z-2729-2016
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. List Number 12618. 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 12618. serial numbers: 14040001, 14040002, 14040003, 14040004, 14040005, 14040006, 14040008, 14040009, 14040010, 14040011, 14040012, 14040014, 14040015, 14040016, 14040017, 14040018, 14040019, 14040020, 14040021, 14040022, 14040023, 14040024, 14040025, 14040026, 14040027, 14040027, 14040027, 14040028, 14040028, 14040028, 14040029, 14040030, 14040031, 14040033, 14040034, 14040034, 14040034, 14040035, 14040036, 14040037, 14040038, 14040039, 14040040, 14040041, 14040042, 14040043, 14040044, 14040045, 14040047, 14040048, 14040049, 14040050, 14040051, 14040052, 14040053, 14040054, 14040056, 14040059, 14040061, 14040062, 14040063, 14040064, 14040065, 14040066, 14040067, 14040068, 14040069, 14040070, 14040071, 14040072, 14040073, 14040074, 14040075, 14040076, 14040077, 14040078, 14040079, 14040080, 14040081, 14040082, 14040083, 14040084, 14040085, 14040086, 14040087, 14040088, 14040089, 14040090, 14040091, 14040092, 14040093, 14040094, 14040095, 14040096, 14040097, 14040098, 14040099, 14040100, 14040101, 14040103, 14040104, 14040105, 14040106, 14040107, 14040108, 14040109, 14040110, 14040111, 14040112, 14040113, 14040115, 14040116, 14040117, 14040118, 14040119, 14040120…
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-2729-2016
- 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-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 |