Medical device alerts archived in May 2015
A list of all medical device alerts that were archived in May 2015.
We’ve reviewed all our medical device alerts and have decided to archive the ones listed below.
| Reference | Title |
|---|---|
| MDA/2003/018 | Expanding Haemostatic Agents and Expanding Tissue Sealants. |
| MDA/2004/011 | ABG I Uncemented Acetabular Cups for Total Hip Replacement |
| MDA/2004/022 | Cidex® OPA ortho-phthalaldehyde high level disinfectant solution. |
| MDA/2005/021 | Prosan Flexi-T 300 intrauterine devices - batch 01A1. |
| MDA/2005/027 | Heat patches or heat packs intended for pain relief. |
| MDA/2005/036 | Biokit Best 2000 laboratory analyser used in combination with the BioMerieux Vironostika HIV Uni-Form II Ag/Ab assay. |
| MDA/2005/041 | Guidant implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) |
| MDA/2005/043 | Styrene polymer based surgical and examination gloves – various manufacturers. |
| MDA/2005/061 | Footswitches for use with all models of ConMed or Valleylab electrosurgical units (ESUs), including footswitches manufactured by third parties. |
| MDA/2005/063 | Lancing Devices - including Roche Accu-Chek Softclix, Softclix II, Softclix Plus and Multiclix lancing devices |
| MDA/2006/036 | Electrically Powered Indoor Wheelchairs (EPICs). |
| MDA/2006/045 | Anaesthetic conserving device: Sedana Medical AnaConDa |
| MDA/2007/013 | Lucas external cardiac compressor, manufactured by Jolife AB and distributed by Medtronic Ltd. |
| MDA/2007/035 | Endoscope storage and drying cabinets: all endoscope storage facilities (ESF) manufactured by AFOS (NSE) Ltd. |
| MDA/2007/051 | All brands of needle-free intravascular connectors. |
| MDA/2007/054 | Total hip replacement: DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation. |
| MDA/2007/056 | Profiling bed: Invacare Scanbed 750, (SB 750) with integral bed rails. |
| MDA/2007/063 | Hip resurfacing implants. Birmingham Hip Resurfacing (BHR) acetabular cups manufactured by Smith & Nephew Orthopaedics Ltd. (see Appendix for affected lot numbers). |
| MDA/2007/065 | Hospital beds: Hill-Rom TotalCare Duo 2. |
| MDA/2007/067 | Hip resurfacing implants. Adept acetabular cups manufactured by Finsbury Orthopaedics (see appendix for affected lot codes). |
| MDA/2007/068 | Hip implants for hemiarthroplasty – Austin-Moore, F.R. Thompson and Thompson Modular endoprostheses manufactured by Biomet UK Ltd. |
| MDA/2007/076 | Bioresorbable Screw: CALAXO interference screw implants manufactured by Smith & Nephew Inc. All lot numbers and all item codes distributed since 2006. |
| MDA/2007/081 | Orthopaedic bone cement restrictor instrumentation. DePuy SmartSeal™ pressurisers- femoral and acetabular pressurisers (5 pack) manufactured by DePuy CMW. |
| MDA/2007/084 | Spinal implants - locking nuts used in the Medtronic Colorado II spinal implant system. Catalogue number 8634111. |
| MDA/2007/085 | Automatic external defibrillator - Welch Allyn AED 20. |
| MDA/2007/088 | Injectable polymeric cements used in percutaneous vertebroplasty, balloon kyphoplasty and pedicle screw augmentation. |
| MDA/2007/092 | Total knee replacement implants. VKS, RT-Plus and TC-Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd (specific lot numbers). |
| MDA/2007/096 | Kimba Spring paediatric buggies manufactured by Otto Bock. |
| MDA/2008/003 | Total knee replacement implants. VKS, RT-Plus and TC-Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew orthopaedics Ltd (specific lot numbers). |
| MDA/2008/005 | Hard-shell venous reservoirs and oxygenators used for cardiopulmonary bypass during heart surgery: various manufacturers. |
| MDA/2008/016 | Needle-free intravascular connectors. All brands. |
| MDA/2008/037 | All posture/safety belts fitted to seating, stair lifts, hoists and wheelchairs. |
| MDA/2008/052 | Puma and Beatle battery powered wheelchairs manufactured by Movingpeople.net or Handicare. |
| MDA/2008/065 | Neurostimulator programmers manufactured by Medtronic – N’Vision® and InterStim iCon® used with InterStim implantable neurostimulator model 3023 for pelvic floor disorders. |
| MDA/2008/066 | Total knee replacement implants: Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts (specific product and lot codes – see Appendix). |
| MDA/2008/077 | Storm3, Storm TT, Typhoon and Typhoon II battery powered wheelchairs manufactured by Invacare. |
| MDA/2009/020 | All Servo ventilators 300 and 300A with automode function. Manufactured by Maquet Critical Care AB (previously Siemens). |
| MDA/2009/047 | Stopcocks (catalogue numbers. W20058 and W21372) and specific products containing non-lipid resistant stopcocks, manufactured by ARROW®. |
| MDA/2009/072 | Tec 6 Plus Desflurane vaporiser manufactured by GE Healthcare (formerly Datex-Ohmeda). Also distributed by Baxter Healthcare. |
| MDA/2010/021 | Anaesthetic gas scavenging systems (AGSS). All manufacturers. |
| MDA/2010/040 | All chest drains when used with high-flow, low-vacuum suction systems (wall mounted). |
| MDA/2010/072 | Vascular catheters: K-Flow Access Catheters. Kimal High Flow (HF) Haemodialysis Catheters. Kimal Right Atrial (KRA) Catheters. Manufactured by Kimal. Devices with specific product codes and expiry dates are affected. |
| MDA/2010/076 | SleepStyle CPAP devices. Manufactured by Fisher & Paykel Healthcare. Specific model and lot numbers are affected. |
| MDA/2010/092 | All Oxylog 3000 emergency/transport ventilators. Manufactured by Draeger. |
| MDA/2011/002 | Peristeen Anal Irrigation System manufactured by Coloplast Limited. |
| MDA/2011/092 | Eleganza Standard (model prefix 1GS) and Deluxe (model prefix 1GL) beds manufactured by Linet prior to December 2005. |
| MDA/2012/002 | Tracheostomy tubes: Bivona® Neonatal, Pediatric and Flextend.Manufactured by Smiths Medical.Lot numbers from 1631477 to 1923406 inclusive. |
| MDA/2012/005 | Stapler. Duet TRSTM universal straight and articulating single use loading units (SULU) Manufactured by Covidien. |
| MDA/2012/019 | Risk of life-threatening or fatal embolism during, or immediately after, application of fibrin sealants using air- or gas-pressurised spray devices. |
| MDA/2012/029 | Neonatal endotracheal tube SCP clamp/holder manufactured by Capatex Medical |
| MDA/2012/032 | RUSCH Mackintosh laryngoscope disposable metallic kit (all sizes) |
| MDA/2012/038 | Mobile patient hoist carabiners manufactured by Invacare |
| MDA/2012/042 | FRED easy Defibrillators manufactured by Schiller |
| MDA/2012/043 | Schiller electrodes: Silver packet, manufactured by Nessler Medizintechnik |
| MDA/2012/044 | Legendair and Supportair Portable Ventilators manufactured by Airox |
| MDA/2012/049 | Neonatal and paediatric endotracheal tube clamp/holder manufactured by EMS Medical |
| MDA/2012/057 | Sterile Water for Irrigation 1000ml. Manufactured by Baxter Healthcare Ltd. Product code: UKF7114. Lot no: 12D10B26 |
| MDA/2012/059 | Animas ambulatory insulin infusion pumps. Animas® IR 1200 Animas® 2020 One Touch® Ping® Glucose management system Animas® Vibe |
| MDA/2012/060 | Powered wheelchairs. All chairs in the Harrier range. Manufactured by Invacare. |
| MDA/2012/064 | Surgical stapler. Duet TRSTM Universal straight and articulating single use loading units (SULU). |
| MDA/2012/068 | ConchaTherm Neptune heated humidifiers. Manufactured by Teleflex. Product codes: 425–00, 425–10 and 425–30. Specific serial numbers. |
| MDA/2012/077 | Defibrillators, Non Implantable Battery |
| MDA/2012/081 | Workstation software for computed tomography systems: Vitrea fX, Vitrea and Vitrea Enterprise Suite. Manufactured by Vital Images. |
| MDA/2013/005 | Laboratory analysers for a variety of tests including HIV, tumour markers and hepatitis. Specific assays. ADVIA Centaur® and ADVIA Centaur® XP, manufactured by Siemens Healthcare Diagnostics Inc. Specific catalogue numbers. |
| MDA/2013/009 | Nasogastric feeding tubes – Ryles tubes (weighted tip). Manufactured by Vygon Ltd. Size 12FG 125cm, product code: 392.12, lot number: 160412FG. Size 14FG 125cm, product code: 392.14, lot number: 100512FF. |
| MDA/2013/012 | Diagnostic test strips and cassettes for urinalysis, pregnancy testing, menopause testing and opiates testing, manufactured by• IND Diagnostics Inc, Canada• Alere International Ltd• Barrier Healthcare Ltd• E-Pharm Ltd |
| MDA/2013/015 | Delivery System - Wound Sealant - EVICEL/QUIXIL Fibrin Sealant (Human) |
| MDA/2013/017 | Infusion Systems Electrically Powered Infusion Pump |
| MDA/2013/022 | Home use blood glucose meters: • Lifescan OneTouch Verio Pro • Lifescan OneTouch Verio IQ |
| MDA/2013/023 | Workstation software for computed tomography systems Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX, all versions prior to version 6.3.3. Manufactured by Vital Images, Inc. |
| MDA/2013/025 | Home use blood glucose meter: FreeStyle InsuLinx manufactured by Abbott Diabetes Care |
| MDA/2013/026 | Suction canisters and liners. All Receptal: 1 litre canisters (List number 43449), 1 litre PVC liners (List number OL212) and 1litre PE liners (List number OL213). Manufactured by Hospira (formerly manufactured by Abbott). All batch numbers. |
| MDA/2013/027 | Peritoneal dialysis transfer sets.Manufactured by Baxter Healthcare Ltd. Product codes: R5C4325, R5C4326, R5C4482, R5C4483 and R5C4484. All batches. |
| MDA/2013/029 | Airway Devices Tube Endotracheal |
| MDA/2013/031 | Hospital beds: Dynamis and Gerialit with Dewert electrical control systems. Manufactured by Hill-Rom. Specific models numbers manufactured from October 1995 to June 2001 inclusive. |
| MDA/2013/033 | Diacap® Ultra dialysis fluid filter. Manufactured by Product code: 7107366. All devices that are more than 10 months from the date of manufacture are affected. |
| MDA/2013/034 | Endoscopes, Rigid Laryngoscope |
| MDA/2013/035 | Paradigm ambulatory insulin infusion pumps. Models: MMT - 511, 512, 712, 712E, 515, 715, 522, 722, 722K, 523, 723, 723K, 554 (VEO) and 754 (VEO). |
| MDA/2013/038 | Rusch Belly Bag urine collection bag with hip belt. Specific product codes. Manufactured by Teleflex Medical. |
| MDA/2013/039 | Workstation software for computed tomography systems: Vitrea CT Brain Perfusion 2D application. Versions 6.0 and above for Vitrea Enterprise Suite, Vitrea, VitreaAdvanced and Vitrea fX are affected. Manufactured by Vital Images, Inc. |
| MDA/2013/040 | Laboratory test kit. Orgentec Alegria dsDNA IgG (ORG204G) for the diagnosis of lupus.Lot numbers: 204G30204 and 204G30205.Manufactured by Orgentec Diagnostika GmbH, distributed in the UK by Launch Diagnostics. |
| MDA/2013/041 | Laboratory test kit: Intrinsic Factor Antibody test strips used in testing for vitamin B12 malabsorption. Alegria Anti-Intrinsic Factor Assay (ORG-247-24) lot number 24723031 expiry 30/11/2013. Manufactured by Orgentec Diagnostika GmbH distributed in the UK by Launch Diagnostics. |
| MDA/2013/043 | Rad-8 Pulse Oximeter with 20-pin patient cable connector. Manufactured by Masimo. Specific serial numbers are affected. |
| MDA/2013/046 | Needle-free IV access device: Double Octopus extension set with 2 Bionectors, anti-reflux valves and clamps Manufactured by Vygon Product code: 0841233 NHS Supply Chain code: FSW388 Lot numbers: 021112AF, 081112AF and 091112AF |
| MDA/2013/047 | Safety blood collection and infusion sets. Manufactured by Greiner Bio-One. |
| MDA/2013/048 | Recall of Hospira 1 litre suction canisters and liners - additional products recalled. Suction canisters and liners with Abbott labels and list numbers are now included in the recall. |
| MDA/2013/049 | Ibis Comfort wheelchair. Manufactured by Handicare B.V. Specific serial numbers of chairs manufactured from 29 January to 12 April 2013 inclusive. |
| MDA/2013/051 | Overhead and Mobile Patient Hoists: Standard Sling Bar 450 (Spreader bar). Specific models numbers. Manufactured By Liko (A Hill-Rom Company). |
| MDA/2013/054R | SLE 4000/5000 ventilator.Power supply unit (PSU) model FP110 – 410.Specific serial numbers.Manufactured by SLE. |
| MDA/2013/056 | Infusion & Transfusion, Administration Sets Extension Set |
| MDA/2013/057 | Spectra series powered wheelchairs. Manufactured by Invacare. Fitted with the Pilot+ digital wheelchair control system supplied by PG Drives Technology |
| MDA/2013/058 | Blood grouping cassettes. OrthoBioVue multi-reagent cassettes. Manufactured by Ortho Clinical Diagnostics. Specific lots. |
| MDA/2013/059 | Orthopaedic instrument. Flexible handle (part no. 355.280), used with the Simplified Universal Nail System (SUN) and the Universal Nail System (UNI). Synthes GmbH. |
| MDA/2013/061 | Vacutainer® multiple sample Luer adaptor for blood sample collection. Catalogue number 367300 (England only - NHS Supply Chain code KFK036). Specific lot numbers are affected. Manufactured by Becton, Dickinson and Company (BD). |
| MDA/2013/062 | Infusion pumps: Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails Manufactured by CareFusion. Specific serial numbers are affected. |
| MDA/2013/063 | TRACOE twist tracheostomy tubes. Manufactured by TRACOE Medical. Distributed in the UK by Kapitex Healthcare Ltd. |
| MDA/2013/064 | Home use blood glucose test strips. GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877), used with the GlucoMen LX and GlucoMen LX PLUS meter manufactured by Menarini. Lot 3212214249, expiry date 31-08-2014 and lot 3212219249, expiry date 31-08-2014. |
| MDA/2013/067 | Infusion & Transfusion, Administration Sets Extension Set |
| MDA/2013/068 | Single use syringes: PlastipakTM 50ml Luer Lok syringe – sterile. Manufactured by BD Medical. Product code 300865. Specific lot numbers. |
| MDA/2013/070 | Insulin infusion sets and reservoirs used with Paradigm ambulatory insulin pumps (manufactured by Medtronic): 1) Paradigm infusion sets (all MMT models, all lot numbers). 2) Paradigm insulin reservoirs (MMT models - 326A and 332A, specific lots). |
| MDA/2013/071 | Growth hormone pens. NordiPen® used with 5mg and 10mg Norditropin® SimpleXx® (‘somatropin’) and NordiPenMate®. Manufactured by Novo Nordisk. |
| MDA/2013/073 | Pressure relieving air mattresses and overlays. All models and maufacturers. |
| MDA/2013/075 | Vacutainer® multiple sample Luer adaptor for blood sample collection. Specific lot numbers affected. Manufactured by Becton, Dickinson and Company (BD). |
| MDA/2013/076 | Ultrasound, Imaging Accessory |
| MDA/2013/077 | Receptal suction canisters and liners. Manufactured by Hospira (formerly manufactured by Abbott). All Abbott and Hospira list numbers are affected. All lot numbers and sizes are affected. |
| MDA/2013/079 | Intravenous administration sets: Primary PlumSet Clave secondary port. Manufactured by Hospira. Specific list numbers are affected. |
| MDA/2013/080 | Perfusor Space infusion pump. |
| MDA/2013/081R | Infusion & Transfusion, Administration Sets Filter |
| MDA/2013/083 | TransRadial artery access kit. Manufactured by Arrow International (a division of Teleflex Medical). Specific part numbers and lot numbers. TransRadial artery access kit. Manufactured by Arrow International (a division of Teleflex Medical). Specific part numbers and lot numbers. |
| MDA/2014/002 | Workstation software for computed tomography systems: VitreaCore® software versions 6.0 to 6.5 inclusive, including all upgrades (except 6.3.1, 6.4.4 and 6.4.5). Manufactured by Vital Images. Workstation software for computed tomography systems: VitreaCore® software versions 6.0 to 6.5 inclusive, including all upgrades (except 6.3.1, 6.4.4 and 6.4.5). Manufactured by Vital Images. |
| MDA/2014/007 | Peristeen anal irrigation system manufactured by Coloplast Limited. |
| MDA/2014/009 | FreeStyle Mini® and FreeStyle® blood glucose monitoring systems manufactured by Abbott Diabetes Care. |
| MDA/2014/013 | S74 Elite Sport Scooter with Leoch 20 amp/hour batteries. Manufactured by Pride Mobility Products Ltd. Specific serial numbers. |
Published 9 June 2015