Medisp Produtos Hospitalares: Citra-Lock 5 4%

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The following devices distributed in the UK by Eurosurgical are affected:silicone implants for plastic surgery: breast implants, pectoral implants, gluteal implants, calf implants, implants for hand surgery, tissue expanders, facial implants, nostril retainers, suspension sheets for breast surgery silicone invasive devices: sizers for silicone implants silicone implants for general surgery: blocks and sheetsThe following devices distributed in the UK by Genesis Medical are affected:implants for urology: testicular implants, penile implants, vaginal stents and periuretheral constrictors

St Jude Medical pacemakers: Identity SR model 5172, Identity DR model 5370 and Identity XL DR model 5376. St Jude Medical programmers: APS III model 3500, APS III model 3510 and Merlin PCS model 3650.

Hospital beds: Hill-Rom TotalCare Duo 2.

Total hip replacement: DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation. DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation. These components were only sold in combination in the UK, France and Italy.

Guidant implantable pacemaker and implantable defibrillator families: INSIGNIA, NEXUS, CONTAK RENEWAL TR, CONTAK RENEWAL TR 2, VENTAK PRIZM 2 VITALITY, VITALITY 2 - See list of affected serial numbers distributed in the UK and the Republic of Ireland on our website. *Not distributed within Europe A comprehensive list of serial numbers of affected devices distributed in the UK and the Republic of Ireland is available on our website.

Cardiovascular Devices

Guidant CONTAK RENEWAL® (model H135) and CONTAK RENEWAL® 2 (model H155) implantable cardiac resynchronization therapy defibrillators (CRT-Ds).

Primus anaesthetic workstation supplied by Draeger Medical UK Ltd. The Primus anaesthetic workstation is a modern machine with an integrated ventilator and gas monitoring system for the administration of anaesthesia to adults, children and neonates.

Cardiovascular Devices

Guidant VENTAK PRIZM® 2 DR implantable cardioverter defibrillator (ICD) model No 1861 - see Appendix for full list of affected serial numbers.

Spinal implants - locking nuts used in the Medtronic Colorado II spinal implant system. Catalogue number 8634111. Lots: W07G2386, W07G2387, W07G2388, W07G2389, W07G2751, W07H0440, W07H1809 and W07H1810.

Lancing devices - including Roche Accu-Chek Softclix, Softclix II, Softclix Plus and Multiclix lancing devices.

Total knee replacement implants: Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts (specific product and lot codes – see Appendix in pdf only).

Cardiovascular Devices

Automatic external defibrillator - Welch Allyn AED 20. Welch Allyn AED 20 defibrillator with automated and manual mode options is distributed mainly in the UK by Response Medical Equipment Ltd. The affected devices can be identified by serial numbers located on the lower right hand corner of the back of the defibrillator. Affected units were manufactured between October 2003 and January 2005. Serial numbers of affected devices are listed in the appendix (in pdf only).

Profiling bed: Invacare Scanbed 750 (SB 750) with integral bed rails.

Anaesthetic conserving device: Sedana Medical AnaConDa. The AnaConDa is a novel anaesthetic conserving device that can be used for administration and recirculation of Isoflurane and Sevoflurane. The AnaConDa must be used with a ventilator, a syringe pump, an anaesthetic gas monitor and a gas scavenging system.

Cardiovascular Devices

Medtronic implantable cardioverter defibrillator (ICD) models GEM® DR 7271 and Micro Jewel® II 7223Cx. Medtronic GEM® DR and Micro Jewel® II ICDs manufactured with suspect capacitors and having serial numbers as indicated in Appendix 2.

Guidant implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) Device Family Model Numbers CONTAK RENEWAL© 4  H190, H195  CONTAK RENEWAL© 4 HE  H197, H199  CONTAK RENEWAL© 4 AVT  M170, M175  CONTAK RENEWAL© 4 AVT HE  M177, M179  RENEWAL© RF  H230, H235  RENEWAL© RF HE  H239

Toshiba ultrasound transducers All models

Animas ambulatory insulin infusion pumps. Animas® IR 1200 Animas® 2020 One Touch® Ping® Glucose management system Animas® Vibe™ Devices distributed before February 2012 and which do not contain the revised keypad are affected.

Autopen 24 1 unit pen Product code: AN4210. PIP code 293-5096. Autopen 24 2 unit pen. Product code: AN4200. PIP code 293-5070. Autopen Classic 1 unit pen. Product code: AN3810. PIP code 273-3178. Autopen Classic 2 unit pen. Product code: AN3800. PIP code 260-3561. To identify affected devices still within their packaging, look for the following packaging lot codes on the outer carton. Packaging lot code Product code Product name 7VJ AN3810 3ml 1 Unit Autopen Classic 7WB AN4200 Autopen 24 3ml 2 Unit 7WC AN4210 Autopen 24 3ml 1 Unit 7WD AN3800 3ml 2 Unit Autopen Classic 8CN AN4200 Autopen 24 3ml 2 Unit 8CP AN4200 Autopen 24 3ml 2 Unit 8CR AN4210 Autopen 24 3ml 1 Unit 8EL AN3800 3ml 2 Unit Autopen Classic 8EM AN3810 3ml 1 Unit Autopen Classic 8JK AN4210 Autopen 24 3ml 1 Unit 8JM AN3800 3ml 2 Unit Autopen Classic 8JN AN3810 3ml 1 Unit Autopen Classic 8JP AN4210 Autopen 24 3ml 1 Unit 8VV AN4200 Autopen 24 3ml 2 Unit 8VW AN4200 Autopen 24 3ml 1 Unit To identify affected devices without packaging look for the following production lot codes, which can be found on the lower part of the pen body. Production lot code (stamped on pen) Product code Product name 7RT AN3810 3ml 1 Unit Autopen Classic 7PN AN4200 Autopen 24 3ml 2 Unit 7PP AN4210 Autopen 24 3ml 1 Unit 7RV AN3800 3ml 2 Unit Autopen Classic 8KK AN3800 3ml 2 Unit Autopen Classic 8XD AN4200 Autopen 24 3ml 2 Unit

Home use blood glucose meters: Lifescan OneTouch Verio Pro Lifescan OneTouch Verio IQ Lifescan OneTouch Verio Pro meters with serial numbers beginning RA, RB, RC, RD and RE have been recalled.  Replacement meters have serial numbers beginning RF. The serial number can be found on the back of the meter itself. Lifescan OneTouch Verio IQ meters with serial numbers beginning TA and TB have been recalled.  Replacement meters have serial numbers beginning TC. The serial number can be found on the back of the meter itself.

Clinical Chemistry and Clinical Toxicology Devices

Home use blood glucose meter: FreeStyle InsuLinx manufactured by Abbott Diabetes Care

Medical oxygen and medical air cylinders filled to 200 atmospheres (200 bar/20,000 kPa). Various sizes and outlets. Supplied by SOL SpA. Medical oxygen at 200 bar with pin index valve in 2, 5 and 50 litre capacity cylinders. Medical oxygen at 200 bar with bull nose valve in 10 and 20 litre capacity cylinders. Medical air at 200 bar with pin index valve in 2, 5, 10, 20 and 50 litre capacity cylinders.