Field Safety Notices: 19 to 23 December 2022
List of Field Safety Notices (FSNs) from 19 to 23 December 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
Acumed: Locking Cortical Screw, Non-Locking Hexalobe Screw
14 December 2022
Model: COL-3140-S, 30-0303-S
MHRA reference: 4632028
Acutronic: fabian HFO, +nCPAP evolution, Therapy evolution
17 October 2022
Model: 111001, 111001.01, 112001, 113001, 122001, 122012, 121001, 121012
MHRA reference: 4641068
Future Diagnostics: STAT-IntraOperative-Intact PTH Immunoassay kit
05 December 2022
MHRA reference: 4632022
Insulet: Omnipod DASH Personal Diabetes Manager (PDM)
17 October 2022
Model: 18239
MHRA reference: 4617868
International Medical Industries: Guarded Luer Connector (GLC)
02 December 2022
Model: 57-400 / 57-400W / 57-401 / 57-402 / 57-403
MHRA reference: 4629491
JRI Orthopaedics: Furlong H-A.C Stem & H-A.C Revision Stem
12 December 2022
Model: Furlong H-A.C Femoral Stem 8mm
MHRA reference: 4624145
LiNA: Librata
14 December 2022
Model: LIB-1
MHRA reference: 4632414
macopharma: Storage solution for blood platelets SSP+
12 December 2022
Model: SSP+ 250ml (UK)
MHRA reference: 4632020
Rayner: RayOne EMV
06 December 2022
Model: RAO200E
MHRA reference: 4595578
Richard Wolf: HOOK ELECTRODE MONO 9FR 0°
09 December 2022
Model: 868895
MHRA reference: 4617650
Roche: Accu-chek solo cannula and kit
06 December 2022
MHRA reference: 5288061
Siemens Healthineers: IMMULITE 2000 Thryoglobulin
December 2022
MHRA reference: 4632510
Siemens Healthineers: Axiom Luminous TF, Luminous DRF MAX, AXIOM ICONOS R200 C90_C, Luminous DRF, Luminous AGILE, Luminous AGILE MAX, Luminous Lotus MAX
Ref UI XP051/22/S
MHRA reference: 4632013
Surgical Holdings: ARTHRODESIS WIRE
12 December 2022
Model: 1.2MM x 100MM LONG TROCAR/TROCAR PACK OF TEN STERILE SINGLES
MHRA reference: 4632505
Teleflex: RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Murphy;
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff;
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff;
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill;
Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Insertion Aid;
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Murphy;
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal;
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal
December 2022
MHRA reference: 4641055
Zimmer Biomet: NexGen Option Stemmed Tibial Component
06 December 2022
MHRA reference: 4643835