Field Safety Notices - 23 January - 27 January 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 23 - 27 January 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
Applied Medical Technology (Use GBUK Healthcare for UK incidents): AMT Bridle - Nasal Tube Retaining System
23 January 2017
Feeding systems and tubes
MHRA reference: 2017/001/026/291/004
Becton Dickinson: BD Plastipak Syringe/ BD Oral Syringe
January 2017
Injection devices
MHRA reference: 2015/009/022/601/003
Becton Dickinson: BD Plastipak™ Syringe, CT with Luer Slip Adaptor
MSS-16-730-FA
Injection devices
MHRA reference: 2017/001/024/701/005
bioMerieux: Etest® References listed Anne 1
16 January 2017
IVDs, bacteriology
MHRA reference: 2016/012/028/071/001
bioMérieux: Etest® XM256 (Cefuroxime)
FSCA 3303
IVDs, bacteriology
MHRA reference: 2017/001/024/291/001
bioMérieux: BK Virus R-gene® Real-time Detection and Quantification Kit
23 January 2017
IVDs, viral microbiology
MHRA reference: 2017/001/024/291/002
Corpak MedSystems: CORFLO* PEG Adapter with ENFit Connectors
16 January 2017
Feeding systems and tubes
MHRA reference: 2017/001/020/291/014
Covidien: Devon™ Light Glove
9 January 2017
Lamps and lights
Model: Devon™ Light Glove
MHRA reference: 2017/001/006/701/015
Diagnostica Stago: STA ® -Cuvettes
January 2017
Coagulation
MHRA reference: 2017/001/026/291/002
Endolologix International Holdings: AFX EndoVascular AAA System
December 2016
Implants, non-active, endoprostheses for aortic aneurysms
Model: All models
MHRA reference: 2016/012/022/601/002
Ethicon: ETHICON PERMA-HAND ® (or MERSILK™) Silk Suture
23 January 2017
Sutures
MHRA reference: 2017/001/023/701/010
Integra LifeSciences (Ascension Orthopedics): Integra ®Cadence ®Total Ankle System
25 January 2017
Joint prosthesis, ankle
Model: various models
MHRA reference: 2017/001/017/701/028
Medicina: Silo bag
6 January 2017
Surgical devices, non-powered
Model: SBxx
MHRA reference: 2017/001/009/601/003
Medline International: Sterile Procedure Trays
FSCA-17/01
Lamps and lights
Model: Sterile procedure trays
MHRA reference: 2017/001/023/291/004
Mölnlycke : ProcedurePak ® trays containing Light Handle Cover (Devon™ Light Glove); See attached Product Table
20 January 2017
Lamps and lights
Model: MHRA reference: 2017/001/020/701/012
Occlutech: Occlutech Occlusions-Pusher, Flex-Pusher II
23 January 2017
Implants, non active, cardiac appendage and septal defect occluders / plugs
MHRA reference: 2017/001/013/299/025
Philips: Cisco 3850 layer 3 switch (WS-C3850-12S-E) with Incompatible Interconnect cable
December 2016
Monitors, patient
MHRA reference: 2017/001/020/291/002
RaySearch: RayStation
18 January 2017
Radiotherapy planning and verification systems
Model: 4.5, 4.7, 5.0, 6.0
MHRA reference: 2017/001/020/701/014
Robinson Healthcare: Instrapac
26 January 2016
Surgical instruments, minimal access
Model: Instrapac; 8258
MHRA reference: 2017/001/026/601/002
Schölly Fiberoptic: EinsteinVision® 3D-Endoskopie-System
25 January 2017
Endoscopes, televisual systems
MHRA reference: 2017/001/026/701/001
Stanmore: Custom-made Medical Device - Glenoid Shell & Proximal Humeral Replacement
20 January 2017
Joint prosthesis, shoulder
Model: PIN 20391
MHRA reference: 2017/001/023/299/002
Vygon: GTUBE 12FG 2L DEHP FREE
26 January 2017
Feeding systems and tubes
Model: VWJKC0100-12LVF
MHRA reference: 2017/001/026/601/003
Wallac: DELFIA Xpress PlGF 1-2-3
25 January 2017
IVDs, clinical chemistry
Model: 6007-0030, 6007-003C
MHRA reference: 2017/001/025/291/013
Zimmer Biomet: Vanguard Open Box Femoral Component
4 January 2017
Joint prosthesis, knee
MHRA reference: 2017/001/023/701/005
Zimmer Biomet: TAPERLOC MICROPLASTY RASP 10 x105mm
15 December 2016
Surgical instruments, non-articulated cutting
MHRA reference: 2017/001/024/701/004