Field Safety Notices - 13 March - 17 March 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 13 - 17 March 2017
Overview
If you receive a field safety notice (FSN) from a manufacturer you must always act on it.
MHRA publishes the following for information only.
If you have a question about a particular FSN contact the manufacturer.
Latest FSNs
Advanced Medical Solutions (Plymouth): LiquiBand FIX8
3 March 2017
Tissue glues
Model: FX001
MHRA reference: 2017/003/003/601/005
Alere Technologies: Alere Afinion™ Lipid Panel Control
February/March 2017
IVDs, clinical chemistry
MHRA reference: 2017/003/001/701/005
Beckman Coulter: Access 2 System, UniCel DxC 600i Syncron System
14 March 2017
IVDs, clinical chemistry
MHRA reference: 2017/003/015/601/003
Buhlmann: CALEX® Cap
21 February 2017
IVDs, bacteriology MHRA reference: 2017/003/014/291/003
bioMérieux: NucliSENS® Lysis Buffer
10 March 2017
IVDs, viral microbiology
MHRA reference: 2017/003/010/299/011
C2 Therapeutics: C2 CryoBalloon Focal Ablation System
13 March 2017
Surgical, cryogenic Model: FG-1012
MHRA reference: 2017/003/014/291/018
CareFusion: Biopsy, Aspiration, Bone Marrow needles and kit
9 March 2017
Surgical instruments, minimal access
MHRA reference: 2017/003/013/701/015
Covidien: Covidien Curity™ Sodium Chloride Dressing; Covidien Curity™ Eye Pad Oval
9 March 2017
Basic dressings, absorbents, swabs, procedure packs
MHRA reference: 2017/003/010/291/002
KARL STORZ: FLIPPTACK, Fixations button
15 March 2017
Osteosynthesis, bone screws
Model: 28729FT
MHRA reference: 2017/003/015/701/011
Medtronic: Medtronic StrataMR™ Adjustable Valves & Shunts
March 2017
Implants, non-active, hydrocephalus shunts
Model: Valves and Shunts: 42955, 42965, 46955, 46960, 46965, and 46970 Adjustment Tools: 45905
MHRA reference: 2017/003/009/291/021
Merit Medical: PreludeSYNC™ Radial Compression Device
1721504-03/03/17-002R
Surgical equipment, tourniquets
MHRA reference: 2017/003/015/291/007
Philips: HeartStart MRx Defibrillator/Monitor
February 2017
Defibrillators, non-implantable
Model: M3535A (M3535ATZ), M3536A (M3536ATZ),
M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
MHRA reference: 2017/003/015/291/022
ROHO: ROHO® HIGH PROFILE® Single Compartment Cushion with Sensor Ready™ Technology; ROHO® MID PROFILE® Single Compartment Cushion with Sensor Ready™ Technology
14 March 2017
Pressure relief cushions
MHRA reference: 2017/003/015/701/013
Siemens: ADVIA Centaur BR 1and 5 Ready Pack Primary Reagent
March 2017
IVDs, clinical chemistry MHRA reference: 2017/003/014/601/002
Stryker: LFIT Anatomic CoCr V40 Femoral Heads
13 March 2017 Joint prosthesis, hip MHRA reference: 2016/009/028/701/006
Thermo Fisher: enGen Laboratory Automation Systems
March 2017 IVDs, clinical chemistry MHRA reference: 2017/003/014/601/001
Verathon Medical: GlideScope GVL 2 Stat
1 March 2017
Airway devices
Model: GVL 2 Stat: 0574-0027 (Single Stat)
MHRA reference: 2017/003/010/291/016
Zimmer: iAssist Validation Tool/SmartTools Knee System
10 March 2017
Orthopaedic surgical instruments - measuring tools
MHRA reference: 2017/003/013/291/008