Hospira Inc

List No. 11971-04 Plum A+ I.V. Infusion Pump; List No. 12391-04 Plum A+ I.V. Infusion Pump;  List No. 12618-04 Plum A+3 I.V. Infusion Pump;  List No. 12348-04 Plum A+3 I.V. Infusion Pump.  List Numbers: 12618-04; List Numbers: 11971-36; (shipped 12391-04; (shipped 11971-04; domestically) 11971-04; internationally) 12391-04;  12348-04; 12348-04;  12391-13; 12391-1312391-1   12618-04. All serial numbers of the above list numbered product are included in this correction.

General Hospital and Personal Use Devices

2

No

Product was distributed nationwide to 746 domestic consignees. Product was distributed internationally to the following countries: Puerto Rico, Canada, Saudi Arabia, Taiwan, Australia, Italy, Jordan, New Zealand, Spain, Turkey, and United Arab Emirates.

Hospira brand Plum A+I.V. Infusion Pump, List No. 11971-04; || Hospira brand Plum A+I.V. Infusion Pump, List No. 12391-04; || Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12618-04; || Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12348-04; || Infusion pump is a multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets. || Product is manufactured and distributed by || Hospira Inc., 755 Jarvis Dr., Morgan Hill, CA

List numbers 12384-04, software version 4.08 and 4.09

General Hospital and Personal Use Devices

2

No

Nationwide. Distributed to 544 domestic consignees, all direct users.

Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09

AC power cords Part Numbers: 826-85559-001,  826-85559-003,  826-85559-008,  826-85559-010, and  826-96057-003.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution

Flexiflo Quantum Enteral Pump, List number 50596, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

AC power cords Part Numbers: 826-85559-001,  826-85559-003,  826-85559-008,  826-85559-010, and  826-96057-003.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution

AC Power Cords, shipped between 06/2005 and 05/2009. These cords were used in the following infusion pump models: Nutrimix, Q-Vue, Q2, Q2 Plus, Ox4, PCA, PCA II, PCA 3, Lifecare PCA, Lifecare 4100, Plum XL 3, Plum XL3M, Plum XL3D, Plum A+/ Plum A+3, and Gemstar Docking Station devices. AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

AC power cords Part Numbers: 826-85559-001,  826-85559-003,  826-85559-008,  826-85559-010, and  826-96057-003.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution

Acclaim Encore Infusion Pump, List # 12569-04-03 (veterinary), 12237 04-15, 12273-04-51, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.