Field Safety Notices: 6 to 10 September 2021
List of field safety notices (FSNs) from medical device manufacturers from 6 to 10 September 2021
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.
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Agilent Technologies: EnVision FLEX Hematoxylin (Link) K8008
30 July 2021
IVDs, cytopathology & histopathology
MHRA reference:
Baxter Healthcare: PrisMax, V2, V3 ROW, Upgrade Kit
27 August 2021
Dialysis, haemofilters
Model: 955725, 955558
MHRA reference:
Beckman Coulter: Access hsTnI Reagent (High Sensitivity Troponin I)
24 August 2021
IVDs, clinical chemistry
Model: B52699
MHRA reference:
Cook Medical: Single Lumen and Double Lumen Ovum Pick-Up Needles
01 September 2021
Surgical instruments, minimal access
MHRA reference:
GE Healthcare: Flow Sensors used in the GEHC anesthesia machines
34120
Anaesthetic machines & monitors
MHRA reference:
Medtronic: Sterile Blade Single-Use Accessories
August 2021
Surgical instruments, non articulated cutting
MHRA reference:
Saluda Medica: Evoke 12C Lead Extension Kit - 55cm
27 August 2021
Implants, active, leads, neuro
MHRA reference:
Smith & Nephew: CPCS Distal Centralizer
30 August 2021
Joint prosthesis, hip
MHRA reference:
STERIS: CMAX 3, CMAX 3-DRIVE, CMAX 3E, and CMAX 3E-DRIVE
07 September 2021
Operating table
MHRA reference:
TORNIER: Inspyre Interpositional Shoulder Implant
06 July 2021
Joint prosthesis, shoulder
Model: All sizes
MHRA reference: