Field Safety Notices: 21 to 25 March 2022
List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 March 2022.
If you receive a field safety notice (FSN) from a manufacturer you must always act on it.
The MHRA publishes the following for information only.
If you have a question about a particular FSN contact the manufacturer.
Latest FSNs
View the latest FSNs
View FSNs since November 2014.
FSNs before this date are on the National Archives website
Abbott: 20/30 INDEFLATOR, INDEFLATOR Plus 30 and Priority Packs
11 March 2022
Vascular cannula and catheters
Model: 1000183, 1000184, 1000185, 1000186, 1000185-115, 1000186-115, 1003327
MHRA reference: 2022/003/009/701/066
Baxter: PrisMax, V2 ROW, V3 ROW
23 March 2022
Dialysis, haemofilters
Model: 955558; 955725
MHRA reference: 2022/003/021/291/007
B.Braun: Simpson Shelf Pessary
14 March 2022
Implants, non active, implantable incontinence and prolapse devices
Model: FG-895-03-K .FG-895-04-M. FG-895-05-P. FG-895-06-R .FG-895-07-T. FG-895-08-V FG-895-09-X FG-895-10-G FG-895-11-J FG-895-12-L FG-895-13-N FG-895-14-Q FG-895-15-S FG-895-16-U FG-895-17-W FG-895-18-Y FG-895-19-Z
MHRA reference: 2022/003/014/601/501
BD: Plastipak Luer-Lok Syringe
25 March 2022
Injection devices
MHRA reference: 2022/003/024/291/004
GE Healthcare: Signa 1.5T TwinSpeed, 1.5T Excite HD, 3.0T Excite HD, Excite 3T, 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, 1.5T Signa HDxt Mobile
60984
Magnetic resonance, equipment & accessories
MHRA reference: 2022/003/016/291/002
Getinge: Getinge 9100-series - Washer Disinfector
08 March 2022
Cssd wash/clean/drying equipment
Model: 9120E, 9122EW, 9125E, 9127E, 9128E, 9128EW
MHRA reference: 2022/003/021/291/001
Medtronic: IN.PACT Admiral (Paclitaxel-coated PTA Balloon Catheter)
March 2022
Vascular cannula and catheters
Model: SBI04004013P, SBI04008008P, SBI04012013P, SBI04015013P, SBI05004008P, SBI05006013P, SBI05012008P, SBI05012013P, SBI05015013P, SBI06004008P, SBI06004013P, SBI06006008P, SBI06008008P, SBI06012013P, SBI06015013P, SBI07004013P, SBI08004013P, SBI10004008P
MHRA reference: 2022/003/024/291/006
Microbiologics: Mycoplasma genitalium Control Panel
25 February 2022
IVDs, bacteriology
Model: (Inactivated Pellet)
MHRA reference: 2022/003/021/291/003
Siemens Healthineers: IMMULITE 2000 HCG
February 2022
IVDs, clinical chemistry
MHRA reference: 2022/003/002/601/001
Z-Medica: QuikClot Interventional Hemostatic Bandage CE – English, n/slit with 3M Tegaderm – Sterile Gauze Pad 1.5 IN x 1.5 IN (3.8CM x 3.8CM)
March 2022
Haemostatic agents
Model: 183 and 188
MHRA reference: 2022/003/016/291/004