—#39084

Product

Hospira brand Plum A+I.V. Infusion Pump, List No. 11971-04; Hospira brand Plum A+I.V. Infusion Pump, List No. 12391-04; Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12618-04; Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12348-04; Infusion pump is a multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets. Product is manufactured and distributed by Hospira Inc., 755 Jarvis Dr., Morgan Hill, CA

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: List No. 11971-04 Plum A+ I.V. Infusion Pump; List No. 12391-04 Plum A+ I.V. Infusion Pump; List No. 12618-04 Plum A+3 I.V. Infusion Pump; List No. 12348-04 Plum A+3 I.V. Infusion Pump. List Numbers: 12618-04; List Numbers: 11971-36; (shipped 12391-04; (shipped 11971-04; domestically) 11971-04; internationally) 12391-04; 12348-04; 12348-04; 12391-13; 12391-1312391-1 12618-04. All serial numbers of the above list numbered product are included in this correction.

Why it was recalled

The pump may shut-off prematurely during battery operation without providing adequate response time when 'E320' service warning message appears.

Root cause (FDA determination)

Other

Action the firm took

On 5/18/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions on the recall.

Recalling firm

Firm: Hospira Inc
Address: 755 Jarvis Dr, Morgan Hill, California 95037-2810

Distribution

Distribution pattern: Product was distributed nationwide to 746 domestic consignees. Product was distributed internationally to the following countries: Puerto Rico, Canada, Saudi Arabia, Taiwan, Australia, Italy, Jordan, New Zealand, Spain, Turkey, and United Arab Emirates.

Timeline

Recall initiated: 2005-05-18
Posted by FDA: 2006-01-12
Terminated: 2006-12-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #39084. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.