Recall Z-1512-2014— Hospira Inc.

Name: FDA recall Z-1512-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-18

Class I · Terminated

Class I FDA medical device recall by Hospira Inc., initiated 2014-02-18, terminated 2017-01-23. It names one FDA 510(k) clearance: K060806. Product: GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX.. Reason: There are two situations that may occur when using the GemStar Docking Station, List Number 13075-XX-XX, in conjunction with the GemStar infusion pump: 1) when the Docking Station is used in conjunction with a GemStar Phase 3 pump (List 13000-XX, 13100-XX, or 13150-XX) the potential exists for the GemStar Phase 3 pump to fail to power up while connected to the Docking Station, and 2) when either a GemStar Phase 3 (List 13000-XX, 13100-XX, or 13150-XX)or GemStar Phase 4 pump (List 13086-XX, 13087-XX, or 13088-XX) is used in conjunction with both a Docking Station and an External Battery Pack accessory (List 13073-XX) there exists a possibility that the GemStar pump will display error code 11/003 and give an audible alarm indicating excessive input voltage from the external sources. If the GemStar pump detects what is perceived to be more than 3.6 Volts measured on the external voltage input, the pump will stop the infusion and alarm both with an audible sound as well as a visual alarm..

Recalling firm: Hospira Inc.
Classification: Class I
Status: Terminated
Initiated: 2014-02-18
Terminated: 2017-01-23
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

GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX.

Reason for recall

There are two situations that may occur when using the GemStar Docking Station, List Number 13075-XX-XX, in conjunction with the GemStar infusion pump: 1) when the Docking Station is used in conjunction with a GemStar Phase 3 pump (List 13000-XX, 13100-XX, or 13150-XX) the potential exists for the GemStar Phase 3 pump to fail to power up while connected to the Docking Station, and 2) when either a GemStar Phase 3 (List 13000-XX, 13100-XX, or 13150-XX)or GemStar Phase 4 pump (List 13086-XX, 13087-XX, or 13088-XX) is used in conjunction with both a Docking Station and an External Battery Pack accessory (List 13073-XX) there exists a possibility that the GemStar pump will display error code 11/003 and give an audible alarm indicating excessive input voltage from the external sources. If the GemStar pump detects what is perceived to be more than 3.6 Volts measured on the external voltage input, the pump will stop the infusion and alarm both with an audible sound as well as a visual alarm.

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