Field Safety Notices: 13 to 17 June 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 June 2022
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website.
Abbott: Alinity hq Analyzer
05 May 2022
IVDs, haematology
MHRA reference: 2022/005/009/701/007
Abbott: Absolute Pro LL Peripheral Self-Expanding Stent Sy
23 May 2022
Implants, non active, peripheral
Model: All model numbers
MHRA reference: 2022/005/019/701/022
Acutronic: fabian HFOi
28 March 2022
Lung ventilators
Model: 113001
MHRA reference: 2022/003/029/291/004
Beckman Coulter: DURAClone B27 Reagent Kit
07 June 2022
IVDs, cytopathology & histopathology
MHRA reference: 2022/006/015/601/001
Bohus BioTech: Microbisc (Ophtheis) family, BBTvisc
17 May 2022
Injectable ophthalmic fluids
MHRA reference: 2022/006/008/611/002
Cordis: PALMAZ GENESIS Peripheral Stent on OPTA Pro
20 May 2022
Implants, non active, peripheral vascular stents
MHRA reference: 2022/005/027/701/061
Covidien: Palindrome Precision Chronic Catheter Palindrome Precision H, Chronic Catheter Palindrome
Precision SI Chronic Catheter Palindrome Precision HSI Chronic Catheter Palindrome Chronic Catheter Palindrome H Chronic Catheter Palindrome SI Chronic Catheter Palindrome HSI Chronic Catheter Mahurkar Chronic Carbothane Catheter
June 2022
Vascular cannula and catheters
MHRA reference: 2022/006/009/595/002
DePuy Synthes: MODULAR CATHCART FRACTURE HEAD HIP BALL Sizes 41mm
14 June 2022
Joint prosthesis, hip
Model: 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 136350000, 136351000, 136352000, 136353000, 136354000, 136356000, 136358000, 136360000
MHRA reference: 2022/006/008/593/003
Drager: Globe-Trotter
May 2022
Infant incubators
Model: MU20508 Globe-Trotter, MU20509
MHRA reference: 2022/005/024/701/021
Groupe Lepin: POWERED CANNULATED REAMER Ø4
18 January 2022
Orthopaedic surgical instruments - cutting tools
MHRA reference: 2022/005/026/611/005
Medtronic: 729808 TruClear Hysteroscopic Tissue Removal System
May 2022
Therapy tissue ablation
MHRA reference: 2022/006/010/590/003
Philips: V680 Ventilator
27 May 2022
Lung ventilators
MHRA reference: 2022/006/008/611/001
Philips: PV.035 Catheter, 90CM White Outer Marking
May 2022
Ultrasound, imaging
Model: 300005384002
MHRA reference: 2022/005/025/601/003
Sodel: SEPTALKAN WIPES
07 June 2022
Disinfectants for medical devices
MHRA reference: 2022/006/014/611/001
Surgical Innovations: YelloPort Elite Universal Seal
02 June 2022
Surgical instruments, minimal access
MHRA reference: 2022/006/002/601/004