Infusion Pumps Recalls

Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers: 0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M13R1, 7M14R1, 7N16R, 7P25R1, 7P93R1, 7Q11R1, BB7L63R2, BB7N26R, CB5174R11, CB175R13, CB5Q03R6, CB5Q03R7, CB6C53R6, CB7C15R2, CB7C59R2, CB7C60R2, CB7C74R2, CB7D91R5, CB7E35R2, CB7E38R1, CB7G21R4, CB7L48R1, CB7L72R1, CB7P82R1, HY6U96R2, HY6Y52R2, HY7E87R1, SS7J91R3, SSCB7L48R, SSTL7G78R1,TL5S33R7, TL6VTTR1, TL7B51R1, TL7G20R3, TL7G78R3, TL7R87R1. Sterilized Using Ethylene Oxide, Nonpyrogenic, Assembled in Mexico, Manufacturer Medtronic, Inc, Minneapolis, Mn 55432 Product is used by perfusionists as part of the extracorporeal circuit during cardiopulmonary bypass procedures, and is configured specifically as designated by each customer.

Medtronic Inc. Cardiac Rhythm Disease Management

Class I - Dangerous

Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility.

Nov 19, 2012 Infusion Pumps Nationwide View Details →

GE Giraffe and Panda T-Piece Resuscitation System labeled T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 MaskM1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 * Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA* Provides the basic equipment required for pulmonary resuscitation of infants.

GE Healthcare

Class I - Dangerous

Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure.

Jun 26, 2012 Infusion Pumps Nationwide View Details →

Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.

Beckman Coulter

Class I - Dangerous

A recall communication was initiated because Beckman has identified that Access Total T4 calibrator lots 019818, 021654, and 024072 do not meet their 12 month expiration date claim.

Jul 27, 2011 Infusion Pumps Nationwide View Details →

Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis.

Arjo, Inc.

Class I - Dangerous

The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.

Dec 10, 2012 Infusion Pumps Nationwide View Details →

Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Medrad

Class I - Dangerous

Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.

Apr 18, 2012 Infusion Pumps Nationwide View Details →

Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Medrad

Class I - Dangerous

Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.

Apr 18, 2012 Infusion Pumps Nationwide View Details →

Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Medrad

Class I - Dangerous

Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.

Apr 18, 2012 Infusion Pumps Nationwide View Details →

AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

BioHorizons Implant Systems

Class I - Dangerous

The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.

Nov 19, 2012 Infusion Pumps Nationwide View Details →

Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Medrad

Class I - Dangerous

Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.

Apr 18, 2012 Infusion Pumps Nationwide View Details →

Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Medrad

Class I - Dangerous

Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.

Apr 18, 2012 Infusion Pumps Nationwide View Details →

Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Medrad

Class I - Dangerous

Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.

Apr 18, 2012 Infusion Pumps Nationwide View Details →

Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic¿ DBSTM Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. STN/GPi target system components: ¿ Kinetra¿ Model 7428 or Soletra¿ Model 7426 Neurostimulator ¿ Activa¿ PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator ¿ Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension ¿ Model 3387 or Model 3389 Lead Medtronic DBS Therapy for Tremor - Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) using Medtronic DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. VIM target system components: ¿ Soletra Model 7426 Neurostimulator ¿ Activa PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator ¿ Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension ¿ Model 3387 or Model 3389 Lead.

Medtronic Neuromodulation

Class I - Dangerous

Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), which may contain a damaged winged connector boot. The connector boot may not have been molded properly and may be cracked. Approximately 14% of the 140 affected extension kits may contain a damaged radiopaque winged connector boot.

Dec 3, 2012 Infusion Pumps Nationwide View Details →

The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.

Beckman Coulter

Class I - Dangerous

Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots have failed the 13-month and 14-month time points. Per BEC's real time stability procedure, in order to verify expiration dating, one additional month is needed beyond the claimed expiration period. Therefore, these lots did not meet BEC's procedural requirements for a 12-month shelf-lif

Nov 5, 2012 Infusion Pumps Nationwide View Details →

EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.

Biomet

Class I - Dangerous

It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.

Nov 9, 2012 Infusion Pumps View Details →

Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. Product Usage: The Arobella Medical AR1000 Wound Therapy System is interned for the selective dissection and fragmentation of tissue, wound debridement ( of acute and chronic wounds, burns, and diseased or necrotic tissue), and cleansing irrigation of the wound site for the removal of debris, exudates, fragments, and other matter.

Arobella Medical

Class I - Dangerous

This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and 0002 can fracture during use and may release a fragment or fragments. The 6 mm Qurette is a component of the AR1000 Quostic Wound Therapy System.

Nov 5, 2012 Infusion Pumps Nationwide View Details →

Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Medrad

Class I - Dangerous

Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.

Apr 18, 2012 Infusion Pumps Nationwide View Details →

Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Medrad

Class I - Dangerous

Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.

Apr 18, 2012 Infusion Pumps Nationwide View Details →

Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.

Zimmer

Class I - Dangerous

Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit .

Nov 19, 2012 Infusion Pumps Nationwide View Details →

Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Medrad

Class I - Dangerous

Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.

Apr 18, 2012 Infusion Pumps Nationwide View Details →

Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Medrad

Class I - Dangerous

Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.

Apr 18, 2012 Infusion Pumps Nationwide View Details →