Materiovigilance – list of recalls

Medical devices – List of recalls and other field safety corrective actions (FSCA)
Date Manufacturer Trade name Product description Information Reference number Swissmedic
20.03.2017 1stQ GmbH

AddOn
Model A4SW00

MD: Anterior-chamber intraocular lens, pseudophakic

de

fr

en

Vk_20170309_02
20.03.2017 Covidien llc

Curity Sodium Chloride Dressing
Model 3339
Lot: see FSN

 

Curity Eye Pad
Model 2841
Lot: see FSN

MD: Sterile wound irrigation solution; Eye pad

de

fr

en

Vk_20170310_05
20.03.2017 Respironics California Inc

V60 Ventilator
Model 850008
Software Version: 2.20

MD: Ventilator

de

fr

en

Vk_20170308_03
20.03.2017 Gambro Lundia AB

Prismaflex System, Prismaflex 4.11, Prismaflex 5.0
Model 107493, 113082, 113874, 114489, 114870, 955052, 6023014700
S/N: All
Software Version: 4.11, 5.00, 6.10, 7.XX, 8.XX

MD: Haemodialysis system, institutional

de

fr

en

Vk_20170307_06
20.03.2017 CareFusion

Biopsy, Aspiration, Bone Marrow needles and kit

MD: Manometer Tray, Jamshidi Needle Biopsy, Illinois (TJ) Needle Aspiration, Jamshidi (TJ) Needle Bone Marrow, Thoracentesis/Paracentesis Kit

en

Vk_20170313_10
20.03.2017 Storz Karl GmbH & Co

FLIPPTACK, Fixationsbutton
Model 28729FT
Lot: 61603728, 61603837, 61603844, 61700023, 61700063, 61700154

MD: Orthopaedic bone screw, non-bioabsorbable, sterile

de

fr

it

Vk_20170313_08
20.03.2017 Zimmer CAS

iAssist Validation Tool/SmartTools Knee System
Model 20-8011-021-00
Lot: 130542A1;1405941;140146;140146-1;140147;140407A;140407A-1;140407B;140407-B-1;140860;140860-1;141035;150120;B150120;B150711

MD: Total knee prosthesis implantation guide-instrument kit

de

fr

it

en

Vk_20170313_04
20.03.2017 JJGC Industria e Comercio de Materiais Dentarios SA - NEODENT

CM Exact Intra oral scanbody
Model 108.139
Lot: 56390; 71065; 71069

MD: Dental implant suprastructure, temporary, single-use

en

Vk_20170308_19
20.03.2017 Sysmex Corporation

Automated Hematology Analyzer XN-L series
Model XN-550
S/N: All

IVD: Haematology analyser

de

fr

it

Vk_20170309_01
20.03.2017 Hitachi High-Technologies

cobas 8000 ISE module 900 / 1800
Model see letter
S/N: see letter

 

cobas c 311 / 501 / 502 / 701 / 702
Model see letter
S/N: see letter

IVD: Ion-selective analyser IVD, automated; Laboratory multichannel clinical chemistry analyser IVD, automated

de

fr

it

en

Vk_20170308_12
20.03.2017 Siemens Healthcare GmbH; Business Area Advanced Therapies

Artis Q/Q.zen
S/N: Artis Q systems with A100G generators

MD: Stationary angiographic x-ray system, digital

de

fr

Vk_20170308_11
20.03.2017 Paul Hartmann AG

Vivano Med Abdominal Kit
Model 4097201, 4097202, 4097203, 4097204
Lot: see fsn

MD: Negative-pressure wound therapy system dressing set

de

fr

Vk_20170309_08
20.03.2017 Physio-Control Corporation

LIFEPAK 1000 Defibrillator
Model 320371500XXX, 99425-000XXX

MD: Non-rechargeable public semi-automated external defibrillator

de

fr

it

en

Vk_20170307_12
13.03.2017 Roche Diabetes Care GmbH

Accu-Chek Insight,
Model 00700006889
Lot: All

MD: Ambulatory insulin infusion pump

de - 1

de - 2

fr - 1

fr - 2

it - 1

it - 2

en -1

en - 2

Vk_20170228_09
13.03.2017 CareFusion Switzerland 317 Sàrl

Pressure Extension Set,
Model 72947NE, 72948NE, 72949NE, 72951NE & 72987NE
Lot: 1000056, 1000078, 1000089, 1000118, 1000129, 1000161, 1000208, 1000468, 1000469, 1000470, 1000471, 1000687, 1000713, 1000784, 1000858, 516641, 517036 & 520847.

MD: Intravenous administration tubing extension set

en

Vk_20170228_03
13.03.2017 Immucor, Inc.

Panocell-20,
Model 0005020
Lot: 52872

IVD: Antibody identification cell panel kit

de

fr

en

Vk_20170301_02
13.03.2017 Medtronic Inc.

Endurant/Endurant II Bifurcated Stent Graft System,
Model Various 23mm and 25mm models
S/N: see fsn

MD: Abdominal aorta endovascular stent-graft

de

it

en

Vk_20170301_08
13.03.2017 Newdeal SAS

Panta and Panta XL Nail,
Model 500050 - 500080 - 500150 - 500180 - 500250 - 500280- 500350- 500380- 510111 - 510141 - 510211-510241 -510311 -510341
Lot: All non-expired and unused products manufactured between 2012 and 2015

MD: Arthrodesis nail, sterile

de

en

Vk_20170306_08
13.03.2017 Inion Oy

lnion Hexalon

 

lnion Trinion

 

lnion GTR Tacks

MD: Orthopaedic bone screw, bioabsorbable<br>Meniscus screw, bioabsorbable<br>Membrane fixation tack, bioabsorbable

de

fr

it

rm

en

Vk_20170301_05
13.03.2017 Immucor, Inc.

Capture-R Ready-ID,
Model 0066204 and 0066214
Lot: ID324 and ID325

IVD: Blood group antibody 2 cell screening kit

de

fr

en

Vk_20170301_09
13.03.2017 Siemens Healthcare Diagnostics Inc.

ADVIA Chemistry Enzyme 2 Calibrator,
Model SMN 10916058
Lot: 6JD079, 6MD042

IVD: Multiple clinical chemistry enzyme IVD, calibrator

fr

en

Vk_20170306_05
13.03.2017 Medtronic Inc.

Medtronic StrataMR Adjustable Valves & Shunts,
Model 42955, 42965, 46955, 46960, 46965, 46970 Adjustment Tools: 45905
Lot: All

MD: Hydrocephalic shunt

de

fr

en

Vk_20170302_05
13.03.2017 Alere Technologies AS

Alere Afinion Lipid Panel Control,
Model 1116072
Lot: 10184874, 10185262, 10185562, 10186155

IVD: Multiple lipid analyte IVD, control

de

fr

it

en

Vk_20170301_01
07.03.2017 Medtronic (formerly HeartWare, Inc.)

HeartWare Ventricular Assist System,
Model 1400, 1401 and 1407
S/N: Controllers with S/N lower than CON300000 and all HeartWare DC Adapters, product code 1435

AIMD: Artificial heart, temporary

de

fr

it

en

Vk_20170301_11
06.03.2017 Phadia AB

EliA Sample Diluent,
Model 83-1023-01
Lot: JU9C, JS0B, JP87, JM3Y, JK5N

 

ImmunoCAP Specific IgA/IgG Sample Diluent, Model 10-9361-01
Lot: JPT7

IVD: Plasma protein IVD, reagent

de

fr

en

Vk_20170222_03
06.03.2017 Becton, Dickinson and Company

BD Vacutainer SST II Advance Plus,
Model 366882
Lot: 6309990

IVD: Evacuated blood collection tube IVD, clot activator/gel separator

de

en

Vk_20170224_10
06.03.2017 Wassenburg Medical Devices B.V.

WD440,
Model MY2010, 201, 202
S/N: MY2010: from serial number 007-480 to 007-978
201: from serial number 201-001 to 201-167
202: from serial number 202-001 to 202-408
Software Version: WA0353A onwards

MD: washer-disinfector for endoscopes

de

fr

en

Vk_20170227_01
06.03.2017 Coloplast A/S

Multi-organ procurement catheter,
Model AJ6516
Lot: 4893648, 4709982, 5066441, 5260931, 5260932

MD: Donor-organ perfusion catheter

de

fr

Vk_20170221_06
06.03.2017 Siemens Healthcare GmbH

AXIOM Artis systems
Software Version: VC14, VC21, VD10, VD11, VE10

MD: Stationary angiographic x-ray system, digital

de

fr

Vk_20170220_14
06.03.2017 Ergo-Fit GmbH & Co. KG

XRCISE STRESS ECHO,
Model V5801-0101, V5801-0102, V5801-0103, V5801-0104
S/N: 1000063645, 1000063818, 1000063981, 1000064429, 1000064430, 1000065062, 1000065337, 1000070160, 1000071254, 1000071780, 1000072027, 10000746611000074705, 1000075593

MD: Stress test table

de

fr

it

en

Vk_20170221_05
06.03.2017 Medica S.p.A

Decapsmart, Modell Estorflow,
Model M03789
S/N: 72000915, 72000114, 72002412, 72003813, 72002812, 72002912, 72000313, 72000815, 72000512
Software Version: 1.0.06, 1.0.07, 1.0.08, 1.1.00, 1.2.00, 1.3.00 und 1.4.00

MD: Haemofiltration system

de

fr

it

Vk_20170224_06
06.03.2017 Hitachi High-Technologies

BRF/URF for cobas 8100 automated workflow series,
Model 07439954001 / 07441657001)
Software Version: 02-xx

IVD: Specimen processing instrument IVD, automated

de

fr

en

Vk_20170222_23
06.03.2017 Möller-Wedel GmbH & Co. KG

CU 5001/3 and CU 3-21/23,
Model 604 105; 604 106; 604 650; 604 700
S/N: 604 105 SN: alle; 604 106 SN: alle; 604 650 Pilot run 5 devices; 604 700 Pilot run 9 devices

MD: Surgical facility boom, ceiling-mounted, microscope

de

en

Vk_20170221_08
06.03.2017 Fresenius Medical Care AG & Co. KGaA

multiFiltratePRO,
Model M20 5001
S/N: all

MD: Haemodialysis system, institutional/home-use

de

fr

it

Vk_20170221_07
06.03.2017 Schwarzer Cardiotek GmbH

Schwarzer eco c und Schwarzer eco
Model see FSN

MD: Cardiac catheterization laboratory computer

de

fr

it

en

Vk_20170220_06
06.03.2017 Hitachi High-Technologies

cobas 8000,
Model e 602 module (05990378001), e 801 module (07682913001)

IVD: Chemiluminescent immunoassay analyser IVD, automated

de

fr

en

Vk_20170227_10
06.03.2017 bioMérieux SA

VIDAS High Sensitive Troponin I,
Model 415386
Lot: 1005255170

IVD: Troponin I IVD, kit, enzyme immunoassay (EIA)

de

fr

en

Vk_20170227_09
06.03.2017 SANO Transportgeraete GmbH

Liftkar PT
S/N: from 20061377 to 20105770

MD: Stairlift

de

Vk_20170215_06
06.03.2017 bioMérieux SA

VITEK 2 Systems AST Test kits,
Model 22108, 414967, 412610

IVD: General-microorganism antimicrobial susceptibility culture medium IVD

de

fr

Vk_20170223_10
06.03.2017 inomed Medizintechnik GmbH

Ball Electrode,
Model 530455
Lot: 15G01D, 15L01D, 16B031D, 16E037D, 16H065D, 16J015D

MD: Electrode

de

en

Vk_20170223_06
06.03.2017 Siemens Healthcare Diagnostics Inc.

ADVIA Chemistry LDLP Reagent,
Model 10309501, 10341128
Lot: All

 

ADVIA Chemistry LDPL Reagent,
Model 10309502, 10341129
Lot: All

IVD: Total lactate dehydrogenase (LDH) IVD, kit, enzyme spectrophotometry

de

fr

Vk_20170223_04
06.03.2017 Bühlmann Laboratories AG

CALEX Cap,
Model B-CALEX-C50, B-CALEX-C200, B-CALEX-C500

IVD: Other containers for samples of human origin

en

Vk_20170222_22
06.03.2017 Zimmer Biomet

Various Polyethylene Implants,
Model See FSN
Lot: See FSN

MD: Unclassified

en

Vk_20170224_13
06.03.2017 Randox Laboratories Ltd

Liquid Cardiac Control,
Model CQS051, CQ5052 & CQ5053
Lot: 30909CK, 3910CK, 3911CK, 3912CK, 3913CK, 3990CK, 3991CK, 3992CK

IVD: Multiple cardiac marker IVD, control

de

fr

it

en

Vk_20170227_02
06.03.2017 Abbott Vascular Inc.

StarClose SE Vascular Closure System,
Model 14679-02
Lot: See FSN

MD: Femoral artery clip-closure kit

de

fr

it

Vk_20170207_08
27.02.2017 Synthes GmbH

Update

MatrixMANDIBLE Screws in Clips
Model see attachment
S/N: see attachment
Lot: see attachment

 

MatrixMIDFACE Screws in Clips
Model see attachment
S/N: see attachment
Lot: see attachment

 

MatrixNeuro Screws in Clips
Model see attachment
S/N: see attachment
Lot: see attachment

 

MatrixORTHOGNATICS Screws in Clips
Model see attachment
S/N: see attachment
Lot: see attachment

MD: Craniofacial bone screw, non-bioabsorbable

de - 1

de - 2

de - 3

fr - 1

fr - 2

fr - 3

en - 1

en - 2

en - 3.1

en - 3.2

Vk_20130419_13
27.02.2017 Cook Incorporated

Check-Flo Hemostasis Assembly, Flexor Radial Access Set, TriForce Peripheral Crossing Set, Performer Hausdorf-Lock Guiding Sheath
Model see fsn
Lot: see fsn

MD: Catheter introducer / Angiographic catheter

de

fr

en

Vk_20170214_07
27.02.2017 Greatbatch Medical

MobiCath Bi-Directional Guiding Sheath
Model D140010, D140011
Lot: see fsn

MD: Catheter introducer

de

fr

it

en

Vk_20170215_05
27.02.2017 Cordis Cashel

Smartflex
Model SF05200MV, SF05200SV, SF06200MV, SF06200SV
Lot: See FSN

MD: Multiple peripheral artery stent, bare-metal

de

fr

en

Vk_20170217_02
27.02.2017 Paul Hartmann AG

CombiSets containing Becton Dickinson 100ml Plastipak Catheter Tip syringe
Model 2482691, 2482692, 2482693, 2484631, 2484632, 2485611, 2488801, 2626192, 2626193, 2642021, 2668565, 2642021
Lot: see FSN

MD: General surgical procedure kit, non-medicated, single-use

de

en

Vk_20170220_12
27.02.2017 Hangzhou AGS MedTech Co., Ltd.

Hemoclip NLS/HC-XL90-26-230
Model AG-51044-2300-090-16
Lot: 510160625, 510160628, 510160810, 510160912

MD: Gastrointestinal endoscopic clip, short-term

de

it

en

Vk_20170208_17
27.02.2017 ELLA-CS

SX-ELLA Stent Danis Procedure Pack
Model 019-08S-25-135, 019-08S-25-135-B

MD: Hybrid/coated oesophageal stent, sterile

de

fr

en

Vk_20170215_01
27.02.2017 Bausch & Lomb Inc.

LASEREDGE Trapezoidal Knife
Lot: All lots with an expiration period from July 2020 to May 2021

MD: Ophthalmic knife, single-use

de

fr

it

en

Vk_20170216_02
27.02.2017 Boston Scientific Corporation

LotusTM Valve System
Model: H749LTV230, H749LTV250, H749LTV270; catalogue: LTV23, LTV25, LTV27
Lot: all

MD: Transcatheter heart valve bioprosthesis, stent-like framework

de

fr

it

en

Vk_20170220_11
27.02.2017 LeMaitre Vascular, Inc.

Reddick Catheters
Model see FSN
Lot: see FSN

MD: Catheter, cholangiography

de

fr

it

en

Vk_20170220_03
27.02.2017 Schölly Fiberoptic GmbH

EinsteinVision 3D-Endoskopie-System
Model EV2-000001 (EV2-000086 display cable)
S/N: All

MD: Casework

de

fr

it

en

Vk_20170125_10
27.02.2017 Mölnlycke Health Care AB

ProcedurePak containing Syringe 100ml 3parts Cath. tip Conc. W/LS Adapter (BD Plastipak Syringe, Catheter tip with Luer slip adaptor)

MD: Orthopaedic - Arthroscopic - General - Urological - Laparoscopic - Obstetrical - gynaecological - Neurosurgical surgical procedure kit

de

fr

en

Vk_20170214_11
27.02.2017 Synthes GmbH

TFNA Helical-Blade Impactor
Model 03.037.024
Lot: T102762

MD: Orthopaedic implant impactor

de

fr

en

Vk_20150623_09
27.02.2017 TORNIER SAS

Radial Head Prosthesis MoPyC
Model Stem / Neck
Lot: all

MD: Elbow radius prosthesis

de

fr

it

en

Vk_20170217_01
27.02.2017 Synthes GmbH

Helical Blade for TFN, Titanium Alloy
Model 456.300(S) - 456.310(S) & 456.650(S)
Lot: 5615864 through 7423581

MD: Spiral blade

de

fr

en

Vk_20131001_04
27.02.2017 Dexcom, lnc.

Update

G4 PLATINUM and G5 Mobilereceiver
Model MT20649-1, MT20649-2, MT22719-1, MT22719-2
Lot: all

MD: Invasive interstitial-fluid glucose monitoring system

de

de - Update

fr

fr - Update

it

it - Update

en

en - Update

Vk_20160225_03
20.02.2017 Siemens Healthcare Diagnostics Products Limited

Sex Hormone Binding Globulin (SHBG) IVD
Model L2KSH2
Lot: 357,358, 360, 361, 363

IVD: Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay

de

fr

Vk_20170213_08
20.02.2017 Nihon Kohden Corp.

Celltac G
Model MEK-9100
S/N: see FSN

IVD: Haematology analyser, cell differential

de

en

Vk_20170210_02
20.02.2017 Abbott, Inc.

HeartMate PHP Percutaneous Heart Pump Catheter
Model 10002111 / 109875
Lot: all

MD: Intracardiac circulatory assist axial-pump catheter

de

fr

it

en

Vk_20170207_06
20.02.2017 Smith & Nephew Inc.

Secura Protective Cream Z10
Model 59447525
Lot: 626110

MD: Skin moisture barrier dressing

en

Vk_20170207_04
20.02.2017 IRIS International

iChemVELOCITY
Model see letter
S/N: all

IVD: Laboratory urine analyser IVD, automated

de

fr

en

Vk_20170208_20
20.02.2017 CareFusion Switzerland 317 Sàrl

Alaris Plus Syringe Pump
Model 8005TIG01
S/N: 500000126
Software Version: V4.1.8

MD: Syringe pump

en

Vk_20170209_04
20.02.2017 Codman & Shurtleff, Inc

Detachment Control Box
Model DCB000001-20, DCB00000500
Lot: All

 

Microcoil Delivery System
Model See FSN
Lot: All

MD: Neurovascular embolization coil

de

fr

en

Vk_20170208_10
20.02.2017 DiaMed GmbH

ID-DiaCell ABO/I-II(-III), ID-DiaCell ABO devices
Model See FSN
Lot: all

 

ID-DiaScreen, ID-DiaCell, ID-DiaPanel, ID-Dia devices
Model See FSN
Lot: all

IVD: Immunohaematology (Blood Grouping)

de - 1

de - 2

fr - 1

fr - 2

it - 1

it - 2

en - 1

en - 2

Vk_20170213_02
20.02.2017 B. Braun Surgical, S.A.

BONE WAX STICK
Model 1029755
Lot: From 212055 to 216363

MD: Bone wax, natural

de

Vk_20170214_01
20.02.2017 Boston Scientific Corporation

AngioJet Ultra System Console
Model see FSN
Lot: see FSN

MD: General-purpose suction system, line-powered

de

fr

it

en

Vk_20170208_11
20.02.2017 Weinmann Emergency Medical Technology GmbH + Co.KG

Batteriepack MEDUCORE Easy
Model 40155

MD: Defibrillator, automatic, external

de

en

Vk_20170216_04
20.02.2017 Zimmer, Inc.

Comprehensive Reverse Shoulder Tray
Model 115340
Lot: see FSN

MD: Reverse shoulder prosthesis body

fr

en

Vk_20170111_07
20.02.2017 Endologix International Holdings B.V.

Update

AFX EndoVascular AAA System
Model all

MD: Abdominal aorta endovascular stent-graft

de

de - Update

fr

fr - Update

it

it - Update

en

en - Update

Vk_20161220_10
20.02.2017 LeMaitre Vascular, Inc.

Update

Hydro LeMaitre Valvulotome
Model 1009-00, 1009-00J
Lot: Update: additional lots affected (see FSN)

MD: Valvulotome

de - 1

de - 2

de - Update

fr - 1

fr - 2

fr - Update

it - 1

en - 1

en - 2

en - Update

Vk_20160809_08