Field safety notice (FSN) 03 to 07 October

List of field safety notices for week 03 to 07 October 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 the 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

BioMerieux: M Hinton Agar

28 September 2022

IVDs, Bacteriology

MHRA reference: 2022/010/001/590/001

CamDiab: mylife CamAPS FX

04 October 2022

Software as a Medical Device (SaMD)

MHRA reference: 2022/010/005/701/053

Coloplast: BD4144, BD4145, BD4146 In-Ka Ureteral balloon dilatation catheter kit

05 October 2022

Vascular Cannula And Catheters

MHRA reference: 2022/010/005/601/001

DePuy Synthes: SE-2020-10, SE-0910, SE-1512 SPEEDSHIFT, BME SPEED, & Hammertoe CCI Implant Kit

27 September 2022 Osteosynthesis, Skeletal Pins, Wires & Staples

MHRA reference: 2022/010/001/590/006

Medtronic: 60480: Endo Stitch V-Loc™ 180 Absorbable Reload 17245: Endo Stitch V-Loc™ PBT Non-Absorbable Reload

September 2022

Sutures

Model: 60480: VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L 17245: VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L MHRA reference: 2022/010/001/590/005

Medtronic UK: MiniMed 640G Insulin Pump (35983); MiniMed 670G Insulin Pump (35983).

September 2022

Infusion Systems

MHRA reference: 2022/009/023/596/010

MicroPort: XFine JX24D MRI, XFine JX25D MRI, XFine TX25D MRI, XFine TX26D MRI.

30 August 2022

Implants, Active, Pacing leads

MHRA reference: 2022/008/026/596/004

Reprolife: Tissue Storage Plate (Warm Plate, Vitri Plate)

30 September 2022

Laboratory Equipment Associated With IVF, Cells, Tissues MHRA reference: 2022/010/006/601/507

Siemens Healthineers: ADVIA Centaur CA 19-9

04 October 2022

IVDs, Clinical Chemistry

Model: 10491244 (1-pack); 10491379(5-pack)

MHRA reference: 2022/010/006/601/509

Smartbox: Talk Pad TP08, TP10, TP13

29 September 2022

Disabled Peoples’ Aids

MHRA reference: 2022/010/004/601/003

Zimmer Biomet: G7 Acetabular System / Ringloc Acetabular Liners

27 September 2022

Joint Prosthesis, Hip

MHRA reference: 2022/010/001/590/002

Zoll: Model 100 AutoPulse Platform (AP) Li-Ion Batteries

28 September 2022

External Cardiac Compression

MHRA reference: 2022/010/002/590/001

Updates to this page

Published 10 October 2022