MHRA - Medical Device Alerts

Medical Device Alerts from Medicines and Healthcare products Regulatory Agency

January 2012

Medical Device Alert: Rüsch Flexislip/Flexi-Slip™ endotracheal tube stylet with soft distal tip, 6F manufactured by Teleflex (MDA/2012/001)

Medical Device Alert: Tracheostomy tubes: Bivona® Neonatal, Pediatric and Flextend manufactured by Smiths Medical (MDA/2012/002)

Medical Device Alert: Catheter valve manufactured by Coloplast (MDA/2012/003)

December 2011

Medical Device Alert: Anaesthetic machine: Auxiliary Common Gas Outlet (ACGO) manufactured by GE Healthcare (MDA/2011/108)

Medical Device Alert: ProcedurePaks manufactured by Molnlycke Health Care (MDA/2011/109)

Medical Device Alert: All Plum A+ infusion pumps manufactured by Hospira Inc (MDA/2011/110)

Specific model variants of Plum A+ infusion pumps manufactured by Hospira Inc - MDA/2011/111

Medical Device Alert: Implantable cardioverter defibrillator (ICD) leads manufactured by St Jude Medical (MDA/2011/112)

Medical Device Alert: Octopus 3 extension set with anti-reflux valves and clamps manufactured by Vygon (MDA/2011/113)

November 2011

Medical Device Alert: Blood glucose analyser manufactured by HemoCue AB (MDA/2011/107)

Metal disposable laryngoscope blades (size Mac 4) manufactured by Penlon Ltd (MDA2011101)

documents/Medical Device Alert Venturi air entrainment jet adapters manufactured by Lifecare Hospital Supplies Ltd (MDA2011102).pdf 
 

documents/Medical Device Alert Wheeled walking aid Nimbo paediatric walkers manufactured by Drive Medical Ltd (MDA2011103).pdf
codp updated

documents/Medical Device Alert Laboratory based syphilis test Mercia Syphilis M kit manufactured by Microgen Bioproducts Limited (MDA2011104).pdf
codp updated

documents/Medical Device Alert Rollators manufactured by Drive Medical Ltd (MDA2011105).pdf
codp updated

documents/Device Alert Endres Riviera Bathlift (MDA2011106).pdf

October 2011

Assura and Sensura sterile post-operative ostomy bags.

Medical Device Alert: Aquarius haemofiltration device manufactured by NIKKISO Europe GmbH (MDA/2011/100)

Medical Device Alert - Legendair ventilator manufactured by Covidien (MDA/2011/098)

September 2011

Reusable laryngoscope handles documents/MDA-2011-096 Re-usable laryngoscope handles.pdf
codp updated

Medical Device Alert: Implantable pacemakers manufactured by Medtronic (MDA/2011/097)

Medical Device Alert: Aquarius haemofiltration machine using software version 6.0 manufactured by Nikkiso Europe (previously Edwards Lifesciences Ltd) (MDA/2011/095)

August 2011

All telescopic bed rails manufactured by Harvest Healthcare Ltd. (MDA/2011/091)

Umbilical cord clamp manufactured by Farla Medical Ltd (MDA/2011/090)

Sterile 2ml Luer lock hypodermic syringe manufactured by Codan Limited (MDA/2011/089)

ROLKO strap and handle assembly fitted to a money pole manufactured by Rolko GmbH and supplied in the UK by ArjoHuntleigh (MDA/2011/088)

Medical Device Alert: All slings manufactured by Nottingham Rehab Supplies (NRS) and/or Moving Solutions (MDA/2011/094)

July 2011

Rollator models 2320, 2340, 2462 and 2463 manufactured by Roma Medical Aids Ltd (MDA/2011/087)

Oxford Easytrack systems for use with overhead hoists manufactured by BHM Medical (MDA/2011/086)

Transactive and transportable overhead hoists manufactured by Waverley Glen (MDA/2011/085)

Blood gas analysers (calcium membrane units) manufactured by Radiometer (MDA/2011/084)

Durewall handling belt supplied in the UK by Prism Medical (MDA/2011/083)

HandyVac™ low vacuum surgical wound drainage systems and accessories manufactured by Unomedical a/s (MDA/2011/082) - Appendix

Ophthalmic surgical instrument - Cryomatic probes manufactured by Keeler Ltd (MDA/2011/081)

Invasive blood pressure monitoring (IBPM) systems manufactured by Smiths Medical (MDA/2011/080)

Implantable Pulse Generators (IPGs) – Neurostimulators manufactured by St Jude Medical (MDA/2011/079)

28% air entrainment (white Venturi) jet adapter for use with oxygen facemasks (MDA/2011/078)

Level 1® Normothermic IV fluid administration sets for use with the Level 1® Fast Flow fluid warmer units manufactured by Smiths Medical (MDA/2011/077)

Level 1® Normothermic IV fluid administration sets manufactured by Smiths Medical (MDA/2011/076)

Headrests attachment to operating tables manufactured by Maquet Ltd. (MDA/2011/075)

Cortoss™ Delivery Gun manufactured by Orthovita Inc and distributed in the UK by Orthovita UK Ltd (MDA/2011/074)

June 2011

Implantable cardioverter defibrillator (ICD) manufactured by Sorin CRM (MDA/2011/073) 

Caretex Urinals (PHURI046) manufactured by PH Medisavers (MDA/2011/072)

Ophthalmic surgical instrument manufactured by Keeler Ltd (MDA/2011/071)

All pyramid clamp adaptors manufactured by Blatchford Products Ltd between October 2007 and February 2011 (MDA/2011/070)

Needle-free intravenous connectors. All manufacturers (MDA/2011/068)

Subcutaneous implantable cardioverter defibrillator (S-ICD): SQ-RX® pulse generator, model 1010. Manufactured by Cameron Health (MDA/2011/067)

All Plum A+ infusion pumps manufactured by Hospira Inc (MDA/2011/066)

Alcohol skin preparation pads, swabs and swabsticks manufactured by Triad Group Inc since 2007 (MDA/2011/065)

Automatic external defibrillators (AEDs). Manufactured by Defibtech (MDA/2011/064)

Neonatal resuscitation systems manufactured by Intersurgical Ltd (MDA/2011/063)

Various products. Manufactured by Boston Scientific (MDA/2011/062)

Power supply for TruSat Pulse Oximeter. Manufactured by GE Healthcare (MDA/2011/061)

Dual Chamber Pacemakers. Manufactured by Medtronic Ltd (MDA/2011/060)

Click-Style gas regulator for pin-index oxygen cylinders. Manufactured by Amvex Corporation (MDA/2011/059)

Medical Device Alert: Pelispec vaginal specula (MDA/2011/069)

May 2011

Enteral feeding pump: Applix Smart and Applix Vision Nutrition pumps. Manufactured by Fresenius Kabi (MDA/2011/058)

BLAKE® and J-VAC™ products. Manufactured by Ethicon (MDA/2011/057)

Pacemaker. Reply and Esprit models that have been interrogated with programmer containing software version 2.24. Manufactured by Sorin CRM (MDA/2011/056)

eXpert® DC Intraoral X-Ray systems manufactured by Gendex Dental Systems and supplied by KaVo Dental Ltd (MDA/2011/055)

Level 1® Normothermic IV fluid administration sets for use with the Level 1 fast flow fluid warmer units. Manufactured by Smiths Medical (MDA/2011/054)

Wound dressing. PremierPore VP Island Dressing. Manufactured by Shermond. Specific lot numbers (MDA/2011/053)

Dermabond® (product code AHV12) and Dermabond™ Mini (product code AHVM12) - topical skin adhesive, manufactured by Ethicon Products, J&J Medical Ltd (MDA/2011/052)

Sprint Fidelis implantable cardioverter defibrillator (ICD) lead, various model numbers manufactured by Medtronic (MDA/2011/051)

Smart 150 mobile hoists manufactured by Molift Group AS, distributed in the UK by Meditec Medical Ltd (MDA/2011/050)

Powder free examination gloves manufactured by BM Polyco Ltd (MDA/2011/049)

Heavy Duty Rollator – titanium coloured manufactured by Nottingham Rehab Supplies (NRS) (MDA/2011/048)

Powerheart AED G3 and CardioVive automatic external defibrillators (AEDs). Manufactured by Cardiac Science Corporation (MDA/2011/047)

Crystal® Metal Miller disposable blades (sizes 0 and 00) manufactured by Penlon Ltd (MDA/2011/046) (Appendix)

Molnlycke Health Care Procedure Paks® (MDA/2011/045)

Blood glucose meters for professional use only: StatStrip Glucose manufactured by Nova Biomedical (MDA/2011/044)

Biogel Eclipse Reveal surgical gloves manufactured by Molnlycke Health Care (MDA/2011/043)

Romachair Anti Microbial Commode, Models 4730/4740, manufactured by Roma Medical Aids Ltd (MDA/2011/042)

April 2011

T34 syringe pump sets manufactured by CME (McKinley Medical UK) (MDA/2011/041)

Eclipse treatment planning system manufactured by Varian Medical Systems Inc (MDA/2011/040)

Quickie Neon Swing-Away manual wheelchairs manufactured by Sunrise Medical (MDA/2011/039)

Oxygen masks and face tent masks manufactured by Unomedical a/s (MDA/2011/038)

Sterile urine drainage bags manufactured by Unomedical a/s (MDA/2011/037)

Alaris® infusion sets manufactured by Carefusion (MDA/2011/036)

HLA (human leukocyte antigen) tissue typing kits manufactured by Invitrogen (MDA/2011/035)

CT scanners manufactured by Philips Healthcare (MDA/2011/034)

Optilube lubricating jelly manufactured by Optimum Medical Solutions (MDA/2011/033)

Airtraq single-use optical laryngoscope manufactured by DragonHeart Medical Co Ltd (MDA/2011/032) 

March 2011

Level 1® Normothermic IV fluid administration sets for use with the Level 1 fast flow fluid warmer units. Manufactured by Smiths Medical (MDA/2011/031)

Action 3 Junior manual wheelchairs manufactured by Invacare (MDA/2011/030) 

Haemodialysis machine manufactured by Gambro Lundia AB (MDA/2011/029)

Microlance 30G x ½” sterile hypodermic needle manufactured by BD Medical (MDA/2011/028) 

Xtreme, Graduate, Junior and Stand-up hoists and standing aids branded and distributed by Harvest Healthcare beween May 2004 March 2006 (MDA/2011/027)

Ligasure blunt tip laparoscopic sealer/divider manufactured by Covidien (MDA/2011/026)

Endotracheal (ET) tubes, adult and paediatric sizes manufactured by Unomedical (a ConvaTec company) (MDA/2011/025)

The Great Ormond Street GOS Tracheostomy Cannula Set manufactured by Teleflex Medical (formerly known as Rusch) (MDA/2011/024)

Alcohol skin preparation pads, swabs, and swabsticks manufactured by Triad Group Inc for H&W cv since 2007 (MDA/2011/023) 

Sutures manufactured by ETHICON (MDA/2011/022)

February 2011

Careline Easi-MT urine collection bag manufactured by Unomedical a/s (MDA/2011/019)

Medical Device Alert: Action 3 NG manual wheelchairs manufactured by Invacare, fitted with the angle adjustable backrest. (MDA/2011/018)

Medical Device Alert: All types, makes and models of breast implants (MDA/2011/017)

Medical Device Alert: PleuraSeal™ Lung Sealant System manufactured by Covidien (MDA/2011/016)

Medical Device Alert: Oxygen masks manufactured by Lifecare Hospital Supplies Ltd (MDA/2011/015)

Medical Device Alert: HLA (human leukocyte antigen) tissue typing kits manufactured by Invitrogen (MDA/2011/014)

Medical Device Alert: Alco-Prep® alcohol skin preparation pads, swabs and swabsticks manufactured by H&W cv since 2007 (MDA/2011/013R)

GemStar pump sets manufactured by Hospira UK Ltd (MDA/2011/012R)

Blood glucose meters for professional use only - Accu-Chek Inform and Inform II manufactured by Roche Diagnostics Limited (MDA/2011/011)

All slings manufactured by The Helping Hand Company for use with patient hoists and standing aids (MDA/2011/010) 

Gemstar pump sets used for epidural infusions or total parenteral feeding (TPN) manufactured by Hospira (MDA/2011/021)

Oxford Voyager fixed ceiling hoist system fitted with X-Y gate system manufactured by BHM Medical, supplied by Sunrise Medical or Joerns Healthcare (MDA/2011/020)

January 2011

Alphaclassic, Alphastar, Betastar and Alphamaxx series mobile operating tables manufactured by Maquet (MDA/2011/009)

All T-Series shower chairs with drop-down armrests manufactured by Freeway Healthcare (MDA/2011/008)

5ml Plastipak Luer-Lok tip sterile syringe manufactured by Becton Dickinson (BD) (MDA/2011/007)

Oxford patient hoist weigh scales, part no. OP97000, supplied by Sunrise Medical or Joerns Healthcare (MDA/2011/006) 

Medical Device Alert: All medical devices (MDA/2011/001)

Medical Device Alert: Peristeen Anal Irrigation System manufactured by Coloplast Limited (MDA/2011/002)

Medical Device Alert: Nasogastric feeding tube with male Luer lock manufactured by Unomedical (MDA/2011/003)

Medical Device Alert: Counterfeit Covidien Nellcor SpO2 Durasensor ® (DS-100A) sensors (MDA/2011/004)

Medical Device Alert: Orthopaedic instruments - stemmed tibial broach impactor and rotating hinge tibial broach impactor used in the Zimmer NexGen complete knee solution instrumentation set (MDA/2011/005)