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U.S. Department of Health and Human Services

Class 2 Device Recall Hospira

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 Class 2 Device Recall Hospirasee related information
Date Initiated by FirmMay 18, 2005
Date PostedJanuary 12, 2006
Recall Status1 Terminated 3 on December 21, 2006
Recall NumberZ-0389-06
Recall Event ID 32077
Product Classification Pump, Infusion - Product Code FRN
ProductHospira 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
Code Information 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. 
Recalling Firm/
Manufacturer		 Hospira Inc
755 Jarvis Dr
Morgan Hill CA 95037-2810
For Additional Information ContactWilly Weinmann
408-782-3519
Manufacturer Reason
for Recall		The pump may shut-off prematurely during battery operation without providing adequate response time when 'E320' service warning message appears.
FDA Determined
Cause 2		Other
ActionOn 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.
DistributionProduct 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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