B. Braun Medical, Inc. - Pain Control Trays - Class 2 Recall
Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 22, 2015 Category: Medical Equipment Source Type: alerts
Integra LifeSciences Corp. d.b.a. Integra Pain Management - Integra Long Epidural Steroid Injection Needle (Tuohy Needle) - Class 2 Recall
Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra¿ Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra¿ Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed tyvek / plastic pouch. The sterilized pouches are subsequently packaged in a case of 10 that is labeled, sealed and distributed to customers. Pain management procedure trays contain Tuohy Epidural Injection Needles to administer steroid medication in the epidural space. The needles are also avail...
Source: Medical Device Recalls - July 10, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - Cios Alpha - Class 2 Recall
Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2015 Category: Medical Equipment Source Type: alerts
Abbott Laboratories - Class 2 Recall
Gemstar¿ Therapy Pain Management I. V. Infusion Pump, List #: 13150-04; 2.9 Software Version (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2015 Category: Medical Equipment Source Type: alerts
B. Braun Medical, Inc. - Various B. Braun pain control convenience trays - Class 2 Recall
CONTIPLEX¿ Continuous Peripheral Nerve Block Tray, CONTIPLEX¿ Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural Anesthesia Tray, ESPOCAN¿ Combined Spinal and Epidural Anesthesia Tray, PERIFIX¿ Continuous Epidural Anesthesia Tray, PERIFIX¿ FX Continuous Epidural Tray, PERIFIX¿ One Continuous Epidural Pediatric Tray; Utilization of Product: Injection of local anesthetics to provide regional anesthesia for pain management. Rout...
Source: Medical Device Recalls - May 5, 2015 Category: Medical Equipment Source Type: alerts
Integra LifeSciences Corp. d.b.a. Integra Pain Management - Integra Long Epidural Steroid Injection Needle (Tuohy Needle) - Class 2 Recall
Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850. Used to administer steroid medication in the epidural space. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2015 Category: Medical Equipment Source Type: alerts
Hospira Inc. - Class 2 Recall
GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The epidural route is recommended to provide anesthesia or administer analgesia for periods up to 96 hours. .. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 25, 2014 Category: Medical Equipment Source Type: alerts
Hospira Inc. - Class 2 Recall
GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The epidural route is recommended to provide anesthesia or administer analgesia for periods up to 96 hours. . (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 25, 2014 Category: Medical Equipment Source Type: alerts
PAIN RELIEVER PLUS (Acetaminophen, Aspirin And Caffeine) Tablet, Film Coated [Carilion Materials Management]
Updated Date: Aug 20, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - August 20, 2014 Category: Drugs & Pharmacology Source Type: alerts
Medtronic Neuromodulation - RestoreUltra and RestoreSensor - Class 2 Recall
Medtronic, Restore¿ (37711), RestoreADVANCED¿ (37713), RestoreADVANCED¿ SureScan¿ MRI (97713), RestoreSENSOR¿ (37714), RestoreSENSOR¿ SureScan¿ MRI (97714),PrimeAdvanced¿ SureScan MRI, (97702),RestoreULTRA¿ (37712),RestoreULTRA¿ SureScan¿ MRI (97712) Itrel¿4 (37703),Itrel¿4 (37704),RestorePrime¿ (37701),PrimeAdvanced¿ (37702), Spinal cord Stimulation for chronic pain. All Restore, PrimeAdvanced¿ and Itrel 4 devices are used for Spinal Cord Stimulation. All Activa devices are used for Deep Brain Stimulation. Restore¿ (Model 37711),...
Source: Medical Device Recalls - April 30, 2014 Category: Medical Equipment Source Type: alerts
Zimmer, Inc. - Trabecular Metal ( TM) - Class 2 Recall
Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661 (Source: Me...
Source: Medical Device Recalls - December 31, 2013 Category: Medical Equipment Source Type: alerts
Integra LifeSciences Corp. d.b.a. Integra Pain Management - Integra Cranial Access Kit - Class 2 Recall
Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra ¿ Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is 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 Cerebrospinal Fluid (CSF), and to monitor ICP. These kits contain all components and accessories required for burr hole access into the cranium. This includes a hand drill with variable adjustable chuck; one or more drill bits with depth guards ...
Source: Medical Device Recalls - December 21, 2013 Category: Medical Equipment Source Type: alerts
Integra LifeSciences Corp. d.b.a. Integra Pain Management - Integra Kits for Epidural Anesthesia Administration - Class 2 Recall
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intend...
Source: Medical Device Recalls - December 18, 2013 Category: Medical Equipment Source Type: alerts
Kimberly-Clark Corporation - KimberlyClark Single Shot Epidural Pain Management Trays - Class 2 Recall
Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 17, 2013 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - RestoreUltra and RestoreSensor - Class 2 Recall
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) systems 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 conditions: - Failed Back Syndrome (FBS) or low back syndrome or failed back - Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk - Postlaminectomy pain - Multiple back operations - Unsu...
Source: Medical Device Recalls - November 1, 2013 Category: Medical Equipment Source Type: alerts
