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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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Date Printed: 03/02/2023