Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0439-05

The Hospira Plum A+3 I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system...

Abbott Medical / initiated 2004-09-08 / Terminated

Hospira Inc began a recall of The Hospira Plum A+3 I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV... on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0439-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Abbott Medical
Product
The Hospira Plum A+3 I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets.
Product code
JFL Ph Rate Measurement, Carbon-Dioxide
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 root cause
Other
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.
Product codes and lots
The following LIST numbers are under recall. All lots (serial numbers) are currently under recall. LIST No. 12618-04 and LIST No. 12348-04.