Field Safety Notice - 8 to 12 May 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 8 May - 12 May 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
View the latest FSNs
ArcRoyal: Inflation Device 30 atm
8 May 2017
Vascular cannula/catheter accessories
MHRA reference: 2017/005/010/291/018
Beckman Coulter: UniCel DxH 800/600 Cellular Analysis Systems
3 May 2017
IVDs, haematology
MHRA reference: 2017/005/004/601/015
Bio-Rad: MONOLISA™ HCV Ag-Ab ULTRA V2
24 March 2017
IVDs, viral microbiology
MHRA reference: 2017/005/003/701/046
Convatec: Various Oxygen Masks
10 May 2017
Anaesthetic & breathing, masks
Model: 104MM 106MM 108-E 108MM 3226-E 3226MM 3230MM 9108MM
MHRA reference: 2017/005/009/701/010
Covidien: Polysorb™ Braided Absorbable Suture
Endo Stitch™ Loading Unit with Polysorb™ Suture Maxon™ Monofilament Absorbable Suture Biosyn™ Monofilament Absorbable Suture
09 May 2017
Sutures
MHRA reference: 2017/005/011/291/013
Erbe Elektromedizin: ERGO-Griffstück für BiClamp E LAP-Zange
13 March 2017
Surgical, diathermy
Model: 20195-240, 20195-245
MHRA reference: 2017/005/010/291/003
Gambro
05 May 2017
Dialysis, haemofilters
Model: Prismaflex
MHRA reference: 2015/007/008/401/501
Implant Direct:Legacy Full-Contour Abutment 3.5mmD Assembly
April 2017
Implants, dental
Model: HLA3-5
MHRA reference: 2017/005/003/601/009
LivaNova: Heater-cooler (1T), Heater-cooler 3T, FlexTherm
03 May 2017
Blood/fluid warming systems
Model: 16-02-50, 16-02-80, 16-02-81, 16-02-82, 16-02-83, 16-02-85, 16-02-95, 16-70-00
MHRA reference: 2017/005/008/701/012
Samsung: GC80
19 April 2017
X Ray, digital acquisition systems
MHRA reference: 2017/004/013/701/016
Smith & Nephew: BHR Acetabular Cup
4 May 2017
Joint prosthesis, hip
Model: BHR Acetabular Cup
MHRA reference: 2017/005/008/291/013
Molnlycke Health Care: See attached Product Table
3 May 2017
Surgical devices, non-powered
MHRA reference: 2017/005/004/701/029
Monica Healthcare: Monica Novii Wireless Patch System
FMI 32053
Monitors, foetal
MHRA reference: 2017/005/008/299/002
Olympus: HF-resection electrode, loop, 24 Fr., 12°
5 May 2017
Surgical, Diathermy
Model: A22201A (0.35 wire), A22201C (0.35 wire, sterile, single use, 12 pcs.), WA22037C (long, sterile, single use, 12 pcs)
MHRA reference: 2017/004/027/701/010
Randox Laboratories: Liquid Cardiac Control
25 April 2017
IVDs, clinical chemistry
Model: CQ5053
MHRA reference: 2017/005/005/601/010
Rocket Medical: R22610-S
CustComp397
Suction equipment
MHRA reference: 2017/005/005/601/002