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U.S. Department of Health and Human Services

Class 2 Device Recall Hospira Plum A I.V. infusion pump

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  Class 2 Device Recall Hospira Plum A I.V. infusion pump see related information
Date Initiated by Firm September 08, 2004
Date Posted January 27, 2005
Recall Status1 Terminated 3 on September 20, 2005
Recall Number Z-0438-05
Recall Event ID 29982
510(K)Number K021350  
Product Classification Ph Rate Measurement, Carbon-Dioxide - Product Code JFL
Product The Hospira Plum A+ I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets.
Code Information The following LIST numbers are under recall. All lots (serial numbers) are currently under recall. LIST No. 11971-04 and LIST No. 12391-04.
Recalling Firm/
Hospira Inc
755 Jarvis Dr
Morgan Hill CA 95037-2810
For Additional Information Contact Technical Support Operations staff
Manufacturer Reason
for Recall
The batteries in Plum A+ and Plum A+3 I.V. infusion pumps may fail prematurely when the pump is operating solely on battery power.
FDA Determined
Cause 2
Action On 9/8/04, all consignees were notified via written letter sent via Federal Express, informing them of the affected products and providing instructions on the recall. The firm will follow up with phone calls to its consignees.
Quantity in Commerce The firm distributed approximately 31,914 units for all model numbers.
Distribution The firm distributed these products to 484 consignees throughout the US, and an undetermined number of foreign consignees. The firm has distributed the product nationwide, excluding AK, HI, NV, NM, SC, and SD. The firm has sent products to Veterans Supply Office Pharmacy, Dept. of Veteran''s Affairs, Vet Admin Medical Center and US Pentitentiary-MC. Foreign countries that have received the product incluide Saudi Arabia, Canada, Puerto Rico and Taiwan.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = JFL and Original Applicant = ABBOTT LABORATORIES