Entity profile compiled from public source records
| Recall # | Product Description | Initiation Date | Status | Action |
|---|---|---|---|---|
| Z-0009-2012 | Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971 b) list 11973 - software version 10.3 c) list 12391 - software version 11.3 d) list 20679 - Hospira MedNet Software e) list 20792 - Driver Product Usage: The Plum A+ dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With their primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield needleless protection systems makes the Plum A+ a convenient and cost-effective infusion system. Reason: Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from the original default setting. This condition could cause a delay in therapy if the clinician is unable to start the device due to the continuous recycling and/or rebooting. | 2011-09-16 | Terminated | View Details |
| Z-0010-2012 | Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With their primary line, secondary line, and piggyback fluid delivery capability, the Plum A+3 is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield needleless protection systems makes the Plum A+3 a convenient and cost-effective infusion system. Reason: Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from the original default setting. This condition could cause a delay in therapy if the clinician is unable to start the device due to the continuous recycling and/or rebooting. | 2011-09-16 | Terminated | View Details |
| Z-0011-2010 | 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. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0011-2012 | Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers. Reason: Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from the original default setting. This condition could cause a delay in therapy if the clinician is unable to start the device due to the continuous recycling and/or rebooting. | 2011-09-16 | Terminated | View Details |
| Z-0012-2010 | 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. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0013-2010 | Flexiflo Quantum Enteral Pump, List number 50596, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0014-2010 | GemStar AC Wall (Mains) adapter, 90-260 volts, universal, list # 13072-04-01, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0015-2010 | GemStar Docking Station (90-260 volts), list numbers 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0016-2010 | LifeCare PCA Plus II, list #01950-04-03, 01950-04-05, 01950-04-07, 01950-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0017-2010 | LifeCare PCA 3, list #s 12384-04-01, 12384-04-03, 12384-04-05, 12384-04-07, 12384-04-09, 12384-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0018-2010 | LifeCare PCA with Hospira Mednet, list numbers 20709-04-01, 20709-04-03, 20709-04-51, 20709-04-53, 20709-04-77; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0019-2010 | Nutrimix Micro Compounder, List #s 11365-04-01, 11365-04-03, 11365-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0020-2010 | Omniflow 4000 Plus, List numbers 40051-04-05, 40051-04-07, 40051-04-09, 40051-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0021-2010 | Plum LifeCare 5000 (Plum 1.6) with Dataport, list #s 02507-04-11, 02507-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0022-2010 | Plum A+ Infusion System (veterinary), list #s 60529-04-01, 60529-04-03, 60529-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0023-2010 | Plum A+3, list #s 12348-04-03, 12348-04-05, 12348-04-07, 12348-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0024-2010 | Plum A+ v.11.X, list #s 12391-04-01, 12391-04-03, 12391-04-05, 12391-04-11, 12391-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0025-2010 | Plum A+ v.10.3, list #s 11971-04-01, 11971-04-03, 11971-04-05, 11971-04-07, 11971-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0026-2010 | Plum A+3 v.11.X, list #s 12618-04-01, 12918-04-03, 12618-04-05, 12618-04-51, 12618-04-07, 12618-04-53; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0027-2010 | Plum A+3 Infusion System with Hospira Mednet, list # 20678-04-01, 20678-04-03, 20678-04-51, 20678-04-77, 20678-04-81, 20678-04-05, 20678-04-53; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0028-2010 | Plum A+ Infusion System with Hospira Mednet, list #s 20679-04-01, 20679-04-03, 20679-04-05, 20679-04-51, 20679-04-77, 20679-04-79, 20679-04-81, 20792-04-01, 20792-04-03, 20792-04-05, 20792-04-51, 20792-04-53, 20792-04-77, 20792-04-79, 20792-04-81, 20792-04-83, 207929-04-87, 20792-04-55; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0029-1010 | Plum XL, list numbers 11555-04-01, 11555-04-03, 11555-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0030-2010 | Plum XLD, list numbers 11859-04-01, 11859-04-03, 11859-04-05, 11859-04-07, 11859-04-09, 11859-04-11, 11859-04-13, 11859-04-51, 12570-04-01 (veterinary); AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0031-2010 | Plum XL 3, list #s 11781-04-01, 11781-04-03, 11781-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0032-2010 | Plum XL3M, List numbers 11845-04-03, 11845-04-05, 11845-04-07, 11845-04-11, 11845-04-13; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0033-2010 | Plum XLM, list #s 11846-04-03, 11846-04-05, 11846-04-07; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
| Z-0034-2010 | Plum XL3D, list #s 11855-04-01, 11855-04-03, 11855-04-05, 11855-04-07; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Reason: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. | 2009-08-11 | Terminated | View Details |
AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.