Integra LifeSciences Corp. d.b.a. Integra Pain Management - Integra Cranial Access Kit - Class 2 Recall
Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 20, 2013 Category: Medical Equipment Source Type: alerts
St. Jude Medical - Eon Mini - Class 2 Recall
Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 1, 2013 Category: Medical Equipment Source Type: alerts
St. Jude Medical - Eon Mini Charging System - Class 2 Recall
Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 17, 2013 Category: Medical Equipment Source Type: alerts
St. Jude Medical - Eon Charging System - Class 2 Recall
Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. Eon Mini: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 17, 2013 Category: Medical Equipment Source Type: alerts
Baxter Healthcare Corp. - INFUSOR SV Elastomeric Infusion Devices - Class 2 Recall
Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2013 Category: Medical Equipment Source Type: alerts
Baxter Healthcare Corp. - FOLFUSOR SV Elastomeric Infusion Devices - Class 2 Recall
Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2013 Category: Medical Equipment Source Type: alerts
Baxter Healthcare Corp. - INFUSOR LV Elastomeric Infusion Devices - Class 2 Recall
Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2013 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - SynchroMed II Implantable Infusion Pump - Class 1 Recall
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II infusion system include the pump, catheter, and catheter accessories. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile sol...
Source: Medical Device Recalls - June 26, 2013 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - SynchroMed II Implantable Infusion Pump - Class 1 Recall
Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The drug is stored in the pump reservoir. Per a programmed prescription, the drug moves from the pump reservoir, through the pump tubing, catheter port, and catheter, to the infusion site. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or...
Source: Medical Device Recalls - June 26, 2013 Category: Medical Equipment Source Type: alerts
Symbios Medical Products, LLC - GOPump Elastomeric infusion PumpKit - Class 1 Recall
GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer. The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 14, 2013 Category: Medical Equipment Source Type: alerts
