Field Safety Notices - 13 - 17 June 2016
List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 June 2016
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
Aspen Medical: Sorbsan
ASPEN R02-2016
Wound management
Model: 1400, 1410, 1415, 1412, 1411, 1420, 1421, 1422, 1423, 1420SA, AG1400 1421SA, 1422SA, 1423SA, 1400N, 1403S, 1410N, 1410S, 1413S, 1415N, 1415S, 1418S
MHRA reference: 2016/005/006/701/007
Beckman Coulter: Access Free T3
15 June 2016
IVDs, clinical chemistry
Model: Access Free T3
MHRA reference: 2016/006/015/601/011
Benmor Medical
NCR0039
Beds and accessories
Model: Aurum
MHRA reference: 2015/005/026/401/023
Cook: Biodesign® Anal Fistula Plug
13 June 2016
Implants, non-active, abdominal & hernia mesh
Model: C-AFPS-0.6X9.5
MHRA reference: 2016/006/015/291/001
Depuy Synthes: Craniofacial bone distractor
08 June 2016
Orthopaedic surgical instruments - measuring tools
Model: [1] 487.962; [2] 487.963; [3] 487.964; [4] 487.965; [5] 487.974; [6] 487.975
MHRA reference: 2016/006/013/291/002
Draeger
June 2016
Infant, warmers
Model: Babytherm 8004 & Babytherm 8010
MHRA reference: 2016/006/014/291/002
Edwards: EV1000 Clinical platform system
03 May 2016
Monitors, patient
Model: EV1000A
MHRA reference: 2016/006/010/701/010
Fisher & Paykel: AIRVO2 Humidifier / myAIRVO2 Humidifie
FA-2016-001 Humidifiers Model: PT101 / PT100
MHRA reference: 2016/006/010/299/009
GE Medical: Discovery 3.0T MR750
FMI 60888-SW Magnetic resonance, equipment & accessories Model: Discovery 3.0T MR750 used with the 3.0T 6 Channel Flex Coil
MHRA reference: 2016/006/007/299/009
Miris: Miris Human Milk Analyzer (HMA) 10-02-001
20 May 2016
IVDs, clinical chemistry
MHRA reference: 2016/006/014/131/002
Lohmann & Rauscher: Metalline wound, drainage, tracheo dressings
09 June 2016
Basic dressings, absorbents, swabs, procedure packs
MHRA reference: 2016/006/010/299/006
Medcomp
14 June 2016
Vascular cannula and catheters Model: Pro-PICC CT; Pro-Line CT
MHRA reference: 2016/006/013/291/023
PerkinElmer: Sterile Filter Tips, 25ul, Nonconductive
16 May 2016
IVDs, clinical chemistry
MHRA reference: 2016/005/025/701/006
QIAGEN: QIAsymphony DSP DNA & Virus/Pathogen Kits
13 June 2016
IVD, genetic testing
MHRA reference: 2016/006/015/701/001
Rex Bionics: REX Rehab
17 June 2016
Orthoses
MHRA reference: 2016/006/009/299/002
Roche: Multiplate® Analyzer
10 June 2016
Coagulation
Model: 06675069001
MHRA reference: 2016/006/015/701/002
Siemens: Dimension
# ® & Dimension Vista # ® Creatinine
08 June 2016
IVDs, clinical chemistry
MHRA reference: 2016/006/010/601/007
Smith & Nephew:LEGION HK BOLT AND SLEEVE
14 June 2016
Joint prosthesis, knee
MHRA reference: 2016/006/015/291/020