Recall Z-2723-2016
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+ Infusion Pump. List Number 11971. 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 11971. Serial numbers: 13120009, 13120017, 13120018, 13120019, 13120026, 13120028, 13120037, 13120041, 13120042, 13120044, 13120057, 13120058, 13120068, 13120071, 13120074, 13120075, 13120082, 13120096, 13120103, 13120104, 13120107, 13120108, 13120109, 13120115, 13120128, 13120138, 13120143, 13120153, 13120160, 13120164, 13120168, 13120171, 13120174, 13120177, 13120186, 13120187, 13120200, 13120205, 13120220, 13120222, 13120223, 13120226, 13120231, 13120235, 13120237, 13120238, 13120239, 13120247, 13120248, 13120249, 13120251, 13120253, 13120262, 13120270, 13120271, 13120277, 13120279, 13120285, 13120293, 13120294, 13120295, 13120297, 13120303, 13120310, 13120311, 13120314, 13120320, 13120329, 13120343, 13120344, 13120346, 13120353, 13120354, 13120357, 13120359, 13120365, 13120366, 13120367, 13120370, 13120385, 13120390, 13120391, 13120394, 13120398, 13120399, 13120401, 13120405, 13120419, 13120422, 13120424, 13120440, 13120441, 13120452, 13120460, 13120462, 13120467, 13120472, 13120483, 13120487, 13120496, 13120502, 13120503, 13120508, 13120537, 13120543, 13120549, 13120557, 13120558, 13120563, 13120565, 13120567, 13120568, 13120576, 13120580, 13120582, 13120585…
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-2723-2016
- 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-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 |
| 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 |