Field Safety Notices: 20 to 24 November 2023
List of Field Safety Notices (FSNs) from 20 to 24 November 2023
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
Draeger: Atlan Family
November 2023
Anesthesia Units
MHRA reference: 27584749
Getinge: 4 Custom Tubing Packs
16 November 2023
Tubing Set, heart-lung bypass
MHRA reference: 27582542
INSTRUCTION BEFORE USE 27582542
Getinge: Acrobat-i Vacuum Positioner System
20 November 2023
Stabilizer, Heart
Model: XP-5000Z
MHRA reference: 27586538
Medivators: Hookup (accessory)
20 November 2023
Model: 2-8-0012-8-0102-8-0142-8-0302-8-0402-8-0702-8-1122-8-1202-8-2102-8-2132-8-2182-8-2362-8-2442-8-2452-8-2462-8-2602-8-2802-8-3122-8-3302-8-3322-8-3342-8-3352-8-3362-8-3382-8-4212-8-4282-8-4312-8-4322-8-4602-8-5112-8-5132-8-5222-8-5232-8-5262-8-5272-8-5282-8-5342-8-5372-8-5392-8-5402-8-6112-8-6122-8-6142-8-6172-8-6232-8-6252-8-6262-8-6272-8-6342-8-6392-8-6402-8-7112-8-7182-8-7402-8-8112-8-9015-8-0105-8-0305-8-0405-8-0505-8-1125-8-1905-8-2105-8-2452-8-001HAN2-8-002HAN2-8-010HAN2-8-030HAN2-8-112HAN2-8-160HAN2-8-210HAN2-8-213HAN2-8-218HAN2-8-245HAN2-8-330HAN2-8-334HAN2-8-335HAN2-8-336HAN2-8-338HAN2-8-421HAN2-8-428CAS2-8-428HAN2-8-431CAS2-8-431HAN2-8-511HAN2-8-526HAN2-8-536HAN2-8-537CAS2-8-537HAN2-8-611HAN2-8-626CAS2-8-627HAN2-8-634CAS2-8-634HAN2-8-640HAN2-8-711HAN2-8-718HAN2-8-811HAN2-8-902H5-8-030HAN5-8-050HAN5-8-112HAN5-8-244HAN
MHRA reference: 38627380 2023/011/020/601/055
Medtronic: SynchroMed II
November 2023
Implantable pumps, Electronic
Model: 8637-20, 8637-40
MHRA reference: 38210371 2023/011/022/601/054
nal von minden: NADAL Strep A Test
09 November 2023
Strep. A - RT & POC
MHRA reference: 27597676
Nouvag: Dispenser DP30
17 August 2023
Bedside infusion pump, single-channel
MHRA reference: 27523030 replaces 27354354
Olympus: High Flow Insufflation Unit
22 November 2023
Laparoscopic insuffla
Model: UHI-4
MHRA reference: 38534664 2025/002/014/601/093
Promedics: Elastic Wrist/Thumb Brace
22 August 2023
Wrist and hand orthosis
Model: WTE
MHRA reference: 27580833
ResMed: AirFit N10/N20/F20/F20NV/F30/F30i-AirTouch N20/F20
20 November 2023
Reference: MWM-2023-FSN-01
ResMed Masks with Magnets
CPAP/BPAP face / nasal mask, reusable
Model: Refer to FSN
MHRA reference: 34710698 Acknowledgement letter
MHRA reference: 34710698 FSN - 2023/011/014/601/087
MHRA reference: 34710698 Physician letter
Rocket Medical: 6FG BLUE Needle Drain
22 November 2023
Model: R58800-06-BD
MHRA reference: 38309943 2023/011/022/601/050