Field safety notices - 28 September to 2 October 2015
List of field safety notices (FSNs) from medical device manufacturers from 28 September to 2 October 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
Depuy Synthes: Pedicle Awl 4.0mm w/Canevasit Handle (388.550)
8 September 2015
Surgical instruments, implant
Model: 388.550 & 388.656
MHRA reference: 2015/009/022/081/002
Encore Medical dba DJO Surgical LLC: RSP Monoblock fixture
23 September 2015
Surgical instruments, implant
MHRA reference: 2015/009/030/701/002
Fenland Laundries: Micronclean sterile packs
28 September 2015
Injection devices
MHRA reference: 2015/009/029/292/010
GI Dynamics: The EndoBarrier gastrointestinal liner
29 September 2015
Implants, non-active, gastric
Model: 40-10-00624
MHRA reference: 2015/009/029/131/002
LifeHealth: IRMA TRUpoint BG cartridge / CC cartridge
16 September 2015
IVDs, extra laboratory testing
MHRA reference: 2015/009/024/701/010
Mathys Ltd. Bettlach: seleXys TH+ and seleXys TPS shell
15 September 2015
Joint prosthesis, hip
MHRA reference: 2015/009/025/051/002
MEDICHEM Diagnostica: Medidrug ALC VB
12 May 2015
IVDs, clinical chemistry
MHRA reference: 2015/008/003/291/003
Mercury Medical: resuscitators
1 October 2015
Bag resuscitator, manual
MHRA reference: 2015/009/009/401/011
Medtronic: Medtronic MiniMed 640G insulin pump
September 2015
Infusion systems
Model: MMT-1711, MMT-1712
MHRA reference: 2015/009/028/292/033
SENTINEL: Ammonia Ultra
22 September 2015
IVDs, clinical chemistry
Model: 60 mL (3x20)
MHRA reference: 2015/009/024/081/015
Siemens Healthcare Diagnostics: ADVIA Chemistry Systems
September 2015
IVDs, clinical chemistry
Model: Alkaline Phosphatase (AMP) Reagent
MHRA reference: 2015/009/024/601/007
Stryker Orthopaedics: LFIT V40 Tapers, V40 Tapers and PCA Tapers Vitallium femoral heads
September 2015
Joint prosthesis, hip
MHRA reference: 2015/009/011/291/003
Welch Allyn: KleenSpec corded illumination system
WA15.01.01
Endoscopes, televisual systems
Model: 78810, 78812, 78814, 78816
MHRA reference: 2015/009/025/081/004