—#34906

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.

FDA product code: JFL — Ph Rate Measurement, Carbon-Dioxide
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K021350
Affected lot / code info: The following LIST numbers are under recall. All lots (serial numbers) are currently under recall. LIST No. 11971-04 and LIST No. 12391-04.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2004-09-08
Posted by FDA: 2005-01-27
Terminated: 2005-09-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34906. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.