Field Safety Notices: 8 to 12 August 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 August 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
Beckman Coulter: iChemVELOCITY Strips
04 August 2022
IVDs, Clinical Chemistry
MHRA reference: 2022/008/005/601/500
Corin: TaperFit
08 July 2022
Joint Prosthesis, Hip
Model: 588.3800, 588.4500
MHRA reference: 2022/007/008/601/001
GE Healthcare: Avance CS2 - Avance CS2 Pro
REF 34127
Anaesthetic Machines & Monitors
MHRA reference: 2022/008/010/590/001
GE Healthcare: Carescape Central Station
Ref 36153
Monitors, Patient
MHRA reference: 2022/008/003/701/124
Getinge: ED-FLOW, ED-FLOW SD
01 July 2022
Cssd Wash/Clean/Drying Equipment
MHRA reference: 2022/007/005/613/006
Immucor: Automated immuClone Anti-K (Kell) IgM
01 August 2022
IVDs, Blood Transfusion
MHRA reference: 2022/008/010/601/504
Intuitive: Large / Medium-Large / Small Clip Applier
August 2022
Clip Appliers
Model: 420230; 420327; 420003; 470230; 470327; 470401
MHRA reference: 2022/008/005/701/041
KeriMedical: KeriLock - Screwed suture anchor kits 2.0 and 4.0
06 July 2022
ligaments, Tendons and Anchors
MHRA reference: 2022/007/026/590/011
Smiths Medical: Level 1 H-2 Pressure Chamber, Level 1 Pressure Chamber Door and Latch Replacement Kit, Latch Assembly H-2 Plus, Door Assembly H-2 Plus
08 August 2022
Blood/Fluid Warming Systems
Model: 7204012, 7204016, 7204017, 7204018, 7204019, 7204020, 7204030, 7204034, 7204036, 7204064, 7204065, 7204068, 7204071, 7204074, CON-7204012, H-2JP, 7802722-DE, 7802722-EN,7203019, 7203020
MHRA reference: 2022/007/014/590/001
Stryker: Aequalis Reversed Fracture Stem Cemented humeral stem Dia. 13mm - L. 130mm and Dia. 15mm
August 2022
Joint Prosthesis, Shoulder
MHRA reference: 2022/008/004/590/005