Recall Z-0095-2015— Hospira Inc.

Name: FDA recall Z-0095-2015
Creator: U.S. Food and Drug Administration
Published: 2014-02-03

Class I · Terminated

Class I FDA medical device recall by Hospira Inc., initiated 2014-02-03, terminated 2017-03-07. It names one FDA 510(k) clearance: K060806. Product: The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.. Reason: The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply..

Recalling firm: Hospira Inc.
Classification: Class I
Status: Terminated
Initiated: 2014-02-03
Terminated: 2017-03-07
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K060806 — HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088Hospira, Inc.·cleared 2006-04-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.

Reason for recall

The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply.

Data sourced from openFDA. This site is unofficial and independent of the FDA.