My HPRA: Register

Summary of Field Safety Notices – June 2016

Notice type: 3rd Party Publications

Date: 04/07/2016

  

Further Information:
Alere
Alere TESTPACK + Plus STREP A with OBC
Advice regarding a device removal. HPRA Ref: V27863


Baxter Healthcare SA
Vivia System
Advice regarding the review of patient results/patient recall/sample retesting is required. HPRA Ref: V27930


Beckman Coulter
Access Free T3
Advice regarding the review of patient results/patient recall/sample retesting is required. HPRA Ref: V28127


bioMérieux SA
Mueller Hinton + 5 % horse blood agar + 20 mg/l beta-NAD (MH-F) ref: 43901 and 43919
Advice regarding a device removal. HPRA Ref: V28184


Boston Scientific International
Boston Scientific Pelvic Organ Prolapse Devices
Advice regarding changes/updates made to instructions for use. HPRA Ref: V27982


Boston Scientific International
Advantage™ and Advantage Fit™ System, Transvaginal Sling / Lynx™ System, Suprapubic Sling / Obtryx™ System, (Curved or Halo), Transobturator Sling / Obtryx™ II System with PrecisionBlue™ Design (Curved or Halo), Transobturator Sling / Solyx™ SIS System, Single Incision Sling
Advice regarding changes/updates made to instructions for use. HPRA Ref: V27982


Cardionovum
Legflow OTW
Advice regarding the use of the device. HPRA Ref: V27594


CONMED Corporation
CORE® Suction Irrigation Handpieces
Advice regarding a device removal. HPRA Ref: V28218


Drägerwerk AG & Co.KGaA 
Babytherm 8004 & Babytherm 8010
Advice regarding changes/updates made to instructions for use. HPRA Ref: V28100


Edwards Lifesciences
EV1000 Clinical Platform System
Advice regarding the use of the device. HPRA Ref: V28095


Ethicon
Ethicon PhysioMesh™ Flexible Composite Mesh
Advice regarding a device removal. HPRA Ref: V27922


Hangzhou Biotest Biotech Co. Ltd 
RightSign HIV 1.2.O Rapid Test Cassette, RightSign HCV Rapid Test Cassette, RightSign HBsAg Rapid Test Cassette
Advice regarding a device removal. HPRA Ref: V28146


IntegraLife
Mini-invasive Achilles tendon suture system Achillon - FSN 1
Mini-invasive Achilles tendon suture system Achillon - FSN 2
Advice regarding a device removal. HPRA Ref: V28214


Kimal plc
Introducer Needle 18G
Advice regarding a device removal. HPRa Ref: V28005


Lohmann & Rauscher
Metalline Wound, Drain, Drain-K, Tracheo dressings
Advice regarding a device removal. HPRA Ref: V28132


Medcomp
Pro-PICC CT; Pro-Line CT
Advice regarding a device removal. HPRA Ref: V28202


Medtronic
MyCareLink Patient Monitor
Advice regarding a device removal. HPRA Ref: V27954


Medtronic Inc.
Temporary Transvenous Pacing Lead
Advice regarding a device removal. HPRA Ref: V28126


Medtronic Inc.
Medtronic DBS Pocket Adaptor Models 64001 and 64002
Advice regarding the use of the device. HPRA Ref: V28213


Medtronic Ireland Limited
Integrity Rapid Exchange Coronary Stent System
Advice regarding a device removal. HPRA Ref: V28210


Microvention Europe
PHIL (Precipitating Embolic Injectable liquid) Non-Adhesive Liquid Embolic System
Advice regarding a device removal. HPRA Ref: V28217


Phadia AB
EliA CCP Assay
Advice regarding the use of the device. HPRA Ref: V27598


Philips Healthcare
Philips IntelliVue Information Center (PIIC) iX
Advice regarding a software upgrade. HPRA Ref: V26221


Siemens
Dimension® clinical chemistry system / Dimension® Creatinine (CRE2) Flex® reagent cartridge
Advice regarding the use of the device. HPRA Ref: V28090


Siemens
ADVIA Centaur XPT System
Advice regarding the use of the device. HPRA Ref: V27983


Siemens Healthcare Diagnostics
Stratus CS Acute Care Diagnostics System / Stratus CS 200 Acute Care Diagnostics System
Advice regarding the use of the device. HPRA Ref: V28228


Smith & Nephew
Biolox® Ceramic Hip Prosthesis
Advice regarding the use of the device. HPRA Ref: V28018


Sorin Group Deutschland GmbH 
Heater/Cooler 1T, Heater/Cooler 3T, FlexTherm
Advice regarding the use of the device. HPRA Ref: V28215


Sorin Group Italia S.r.l.
Lilliput Pediatric Oxygenator Mounting Brackets
Advice regarding a device removal. HPRA Ref: V28174


Sorin Group Italia S.r.l.
Avant & Primo2x Families Adult Oxygenator Mounting Brackets
Advice regarding a device removal. HPRA Ref: V28175


Stryker  
AutoPlex® System
Advice regarding a device removal. HPRA Ref: V28229


Stryker Neurovascular
Target Detachable Coils
Advice regarding a device removal. HPRA Ref: V28064


Xiros
Infinity-Lock. FSN 1
Infinity-Lock. FSN 2
Advice regarding a device modification. HPRA Ref: V28209


Zimmer Biomet
Taperloc Hip Laterlised PC Stem
Advice regarding a device removal. HPRA Ref: V28211
 

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