Field Safety Notices: 9 to 13 August 2021
List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 August
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
B Braun: MONOSYN UNDYED 5/0 (1) 45CM DGMP13
27 July 2021
Sutures
Model: C0023706
MHRA reference: 2021/008/003/601/002
Baxter: Prismaflex M60 set, M100 and TPE 2000
02 August 2021
Dialysis, blood lines
MHRA reference: 2021/007/030/487/005
BD: Jamshidi Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle
05 August 2021
Surgical instruments, minimal access
MHRA reference: 2021/008/002/487/011
BioMerieux: VIDAS EBV VCA IgM
05 August 2021
IVDs, bacteriology
MHRA reference: 2021/008/004/000/014
Cair LGL: Polyurethane enteralfeeding Tubes
13 July 2021
Feeding systems and tubes
Model: NCE…PU, NCE…AU, NCE…G
MHRA reference:2021/008/011/291/012
Cordis: SUPER TORQUE MB Angiographic Catheter
04 August 2021
Vascular cannula and catheters
MHRA reference: 2021/008/010/701/033
Leica: BOND Ready-to-Use Primary Antibody CDX2 (EP25)
28 July 2021
IVDs, cytopathology & histopathology
Model: PA0375
MHRA reference: 2021/007/029/601/506
LeMaitre Vascular: XenoSure Biologic Patch
23 July 2021
Implants, non-active, surgical vascular grafts & patches
Model: 0.6BV8, 0.8BV8, 1BV6, 1BV10, 1BV14, 1.5BV10, 2BV9, 2.5BV15, 4BV4, 4BV6, 5BV10, 6BV8, 8BV14, 10BV16
MHRA reference: 2021/008/009/601/501
Philips: EPIQ Ultrasound system
28 July 2021
Ultrasound, imaging
Model: Elite, 5G, 5C, 5W, 7G, 7C, 7W, CVx & CVxi
MHRA reference: 2021/007/029/291/003
Richard Wolf: COAG ELECTRODE BIPO 24-26FR 12/30°
09 August 2021
Surgical, diathermy
Model: 46230223
MHRA reference: 2021/008/011/291/011