Field Safety Notices: 28 September to 02 October 2020
List of field safety notices (FSNs) from medical device manufacturers from 28 September to 02 October 2020
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
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American Medical Systems (Boston Scientific): AMS 700 with MS Pump Penile Prosthesis
92589899-FA Implants, non-active, reproductive system implants MHRA reference:
Baxter: PrisMax
2 October 2020
Dialysis, haemofilters
MHRA reference:
CHIRANA T.Injecta: Sterile hypodermic / blunt fill needle - MEDOJECT
11 September 2020
Injection devices Model: 0,8(21G)x40mm, 1,2(18G)x40mm, 1,8(15G)x40mm
MHRA reference:
Cook Medical: Percutaneous Neonatal Pigtail Nephrostomy Set & Pediatric Nephrostomy Stent Set
11 September 2020 Urinary catheters and accessories MHRA reference:
FUJIFILM: FUJIFILM 580-U Series and 700 Series
20160812 Endoscopes
Endoscopes, flexible Model: EC-760R-V/M, EC-760R-V/I, EC-760R-V/L, EC-760ZP-V/M, EC-760ZP-V/L, EG-760R, EG-760Z, EG-580UT, EG-580UR MHRA reference:
FUJIFILM: FCR Profect CS Plus
FFID_20200908
Mammography MHRA reference:
GS Elektromed. Geraete G. Stemple: corpuls3
17 September 2020
Defibrillators, non-implantable Model: 04301
MHRA reference:
KARL STORZ: KARL STORZ OR1 FUSION CONTROL
29 September 2020
Monitors, patient Model: WO300
MHRA reference:
Smith & Nephew: IODOFLEX Dressing 3 X 10g
21 September 2020
Wound management MHRA reference:
Stryker: Osteosynthesis Compression Staple EasyClip
September 2020
Staples and staple guns MHRA reference: