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 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