Field Safety Notices - 20 February - 24 February 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 20 February - 24 February 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
Acumed: Acumed 045" X 6" ST & 054" X 7" ST Guide Wire
20 February 2017
Osteosynthesis, skeletal pins, wires and staples
Model: 45-0029-S & 45-0031-S
MHRA reference: 2017/002/022/291/002
B. Braun Surgical: Bone Wax Stick
15 February 2017
Bone cement and tools
Model: 1029755
MHRA reference: 2017/002/013/601/003
Bauch& Lomb: Laseredge trapezoidal Knife
23 February 2017
Surgical Instruments, non-articulated cutting
MHRA reference: 2017/002/016/701/015
Cordis Cashel: Smartflex
16 February 2016
Implants, non-active, peripheral vascular stents
Model: Peripheral Vascular Stent
Smartflex
MHRA reference: 2017/002/017/291/009
Encore Medical: RSP Monoblock Fixture
14 February 2017
Orthopaedic surgical instruments - insertion/extraction tools
Model: Insertion Instrument
MHRA reference: 2017/002/021/701/009
GE Medical: RFX/SFX, Legacy, Precision 500D
GEHC Ref# FMI 10908
X-ray, fluoroscopy systems
MHRA reference: 2017/002/020/701/013
Guardian Surgical: Guardian
16 February 2017
Basic dressings, absorbents, swabs, procedure packs
Model: Guardian; CHX001/001, CHX002/002, RO015456, 15.12.116, 15.88.002
MHRA reference: 2017/002/009/601/010
LeMaitre Vascular: Reddick Catheters
17 February 2017
Vascular cannula and catheters
Model: 2401-50, 2401-51, 2401-52, 2401-53
MHRA reference: 2017/002/020/701/012
Nipro Corporation: Hypodermic Needle/ Safety Hypodermic needle
20 February 2017
Injection devices
Model: HN-SF 1925 ET/HN-1925-ET/HN19-38-ET
MHRA reference: 2017/002/020/701/021
Ortho Solutions: AFN Nail Alignment Shaft
23 February 2017
Orthopaedic Surgical instruments - Insertion/extraction tools
Model: OS333503
MHRA reference: 2017/002/023/701/013
Phadia: EliA Sample Diluent, ImmunoCAP Specific IgA/IgG Sample Diluen
QA2017-01
IVDs, immunology
MHRA reference: 2017/002/001/601/022
Siemens Healthcare: ADVIA Chemistry LDLP and LDPL Reagent
February 2017
IVDs, clinical chemistry
MHRA reference: 2017/002/015/601/005
Synergy: Plain Fast Edge Ribbon Gauze
17 February 2017
Basic dressings, absorbents, swabs
MHRA reference: 2017/002/020/701/011
Thoratec Corporation: HeartMate PHP™ Percutaneous Heart Pump Catheter
6 February 2017
Cardiac assist pumps
MHRA reference: 2017/002/007/291/006
Tornier SAS: Radial Head Prosthesis
17 February 2017
Joint prosthesis, elbow
Model: Radial Head Prosthesis; Stem / Neck
MHRA reference: 2017/002/017/291/008
Zimmer Biomet: Comprehensive Reverse Shoulder Tray
1 February 2017
Joint prosthesis, shoulder
MHRA reference: 2016/012/030/701/004