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Terminated

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 Recall Z-0389-06 · Posted 2006-01-12

Recalling FirmHospira Inc
Recall StatusTerminated
Product CodeFRN
Date Initiated2005-05-18
Date Terminated2006-12-21

Reason for Recall

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

Firm Action

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.

Root Cause

Other

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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