Field safety notices - 13 to 17 July 2015
List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 July 2015.
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
Atom Scientific Limited: Neutral red 0.5% aqueous, Gram stain kit (neutral red counterstain) (RRSP109, RRSK5)
CCR21/150415
IVDs, cytopathology & histopathology
MHRA reference: 2015/007/014/291/007
Bio-Rad Medical Diagnostics GmbH: Anti-Jka (JK1)
10 July 2015
IVDs, blood transfusion
Model: 808176
MHRA reference: 2015/007/014/291/015
Cook Medical: Flexor RTPS guiding sheath
08 June 2015
Vascular cannula and catheters
Model: KCFW-10.0-35-RB-RTPS-100
MHRA reference: 2015/007/009/601/016
Cook Medical: Beacon® Tip angiographic catheters
02 July 2015
Vascular cannula and catheters
MHRA reference: 2015/007/013/291/011
DePuy Synthes: ATTUNE® INTUITION™ tibial articulation surface instrument
June 2015
Trial tibial knee insert
MHRA reference: 2015/007/014/291/010
Intuitive Surgical: da Vinci Xi (IS4000) instrument arm drape
03 July 2015
Surgical drapes, gowns, masks
Model: 470015-05, 470015-06
MHRA reference: 2015/007/009/701/017
Invacare: Reliant 350
10 July 2015
Moving & handling
Model: all models
MHRA reference: 2015/007/014/291/018
Medtronic: EnVeo R loading system
July 2015
Implants, non-active, cardiovascular heart valves
Model: LS-ENVEOR-23 and LS-ENVEOR-2629
MHRA reference: 2015/007/016/291/004
Northern Digital: Disposable reflective marker sphere (DRMS)
10 July 2015
Surgical Navigation System
Model: 41773, 41774, 41813
MHRA reference: 2015/006/026/291/015
Ortho Solutions: UltOS 3.5mm locking screw / UltOS 2.7mm locking sc
14 July 2015
Osteosynthesis, bone screws
Model: UltOS
MHRA reference: 2015/007/014/291/006
Philips Healthcare: Allura Xper systems
16 June 2015
X-ray, fluoroscopy systems
Model: 722010, 722011, 722012, 722013, 722022, 722023, 722024 and 722025
MHRA reference: 2015/007/014/291/003
Radiometer: Fixation kit N20
FAN 915-340
Diagnostic measurement and monitoring
MHRA reference: 2015/007/006/291/010
Siemens Healthcare Diagnostics: ADVIA Chemistry acetaminophen reagent
June 2015
IVDs, clinical chemistry
Model: SMN 10327381
MHRA reference: 2015/007/001/601/007
Stryker: SERFAS 900 energy probe (also known as 90R probe)
13 July 2015
Surgical, diathermy
MHRA reference: 2015/007/014/291/005
WallacOy: DELFIA Xpress PIGF kit
09 July 2015
IVDs, clinical chemistry
Model: 6007-001 0, 6007-0020, 6007-002C
MHRA reference: 2015/007/014/291/004
Wilson Instruments (SHA) Co: Single use disposable cleaning brush WS-1523WA(P)DH
Date of FSN / FSN reference (normal style)
Endoscopes, flexible
MHRA reference: 2015/005/021/401/013