Field Safety Notice: 06 to 10 January 2020
List of field safety notices (FSNs) from medical device manufacturers from 06 to 10 January 2020.
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 the latest FSNs
Depuy Synthes: SPECIALIST® 2 DISTAL FEMORAL CUTTING BLOCK
03 January 2020
Orthopaedic Surgical instruments - Measuring tools
MHRA reference: 2020/001/002/228/017
Eurogine: FSN 21022018
25 September 2019
Implants, non active, contraceptive implants
Model: Ref. 01030000 ANCORA 375 Cu Normal
Ref. 01030400 ANCORA 375 Ag Normal
Ref. 01030200 ANCORA 250 Cu Mini
Ref. 01010500 NOVAPLUS® T 380 Ag Normal
Ref. 01010600 NOVAPLUS® T 380 Ag Mini
Ref. 01010700 NOVAPLUS® T 380 Ag Maxi
Ref. 01020100 NOVAPLUS® T 380 Cu Normal
Ref. 01020200 NOVAPLUS® T 380 Cu Mini
Ref. 01040000 GOLD T® Maxi
Ref. 01040100 GOLD T® Normal
Ref. 01040200 GOLD T® Mini
MHRA reference: 2020/001/009/291/003
GE Healthcare: Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation and Giraffe OmniBed Carestation
GEHC Ref 32070-2
Infant incubators
MHRA reference: 2020/001/003/228/004
Karl Storz: Surgical Equipment, Minimal Access
23 December 2019
Surgical equipment, minimal access
Model: 030247-10 W-027318
030247-10 W-027622
030247-10 W-029299
030247-10 W-028852
030247-10 W-029546
031123-10 W-029606
031200-03 W-028530
031200-03 W-028538
031200-03 W-029601
031200-03 W-029596
031200-10 W-027781
031200-10 W-029053
031200-10 W-028738
031200-10 W-029058
031200-10 W-028726
031200-10 W-028592
031200-10 W-028702
031200-10 W-029048
031200-10 W-029561
031200-10 W-029536
031200-10 W-029427
031222-10 W-027713
031222-10 W-027720
031222-10 W-027808
031222-10 W-028719
031222-10 W-028611
031222-10 W-027786
031222-10 W-028120
031222-10 W-028707
031222-10 W-029273
031222-10 W-029280
031322-10 W-027197
031322-10 W-028171
031322-10 W-027939
031322-10 W-028207
031322-10 W-029039
031322-10 W-029437
031322-10 W-029442
031322-10 W-029531
031322-10 W-029541
031322-10 W-029566
031432-10 W-029261
031432-10 W-028543
031432-10 W-029432
031532-10 W-026437
031532-10 W-026871
031532-10 W-027332
031532-10 W-028922
031532-10 W-028928
031532-10 W-028940
031532-10 W-028934
031622-10 W-029555
MHRA reference: 2020/001/003/228/001
Kehler Straße 31(Getinge): QUADROX-iD Pediatric with BIOLINE Coating
24 October 2019
Infusion & transfusion, heart lung circuits
Model: 70104.7041, 70105.0330
MHRA reference: 2019/010/028/487/020
LifeFitness (SciFit): SCIFIT Treadmills
04 July 2017
Diagnostic measurement and monitoring
Model: Scifit CEMed AC5000 TM 220V
MHRA reference: 2019/012/020/601/003
Medicina Ltd: Medicina Oral Enteral and ENFit Syringes
10 October 2019
Feeding systems and tubes
Model: OT01, LHE01LD, LHE01
MHRA reference: 2019/010/010/601/004
Nipro Medical: Vacumed® BLOOD COLLECTION SET
10 December 2019
Storage & collection devices
MHRA reference: 2019/012/019/291/002
Peters Surgical (MNE/19-194): SINGLE USE MONOPOLAR CABLE
08 January 2020
Surgical, diathermy
MHRA reference: 2020/001/009/291/001
Peters Surgical (MNE/19-191): SINGLE USE MONOPOLAR SCISSORS - IN CUT
08 January 2020
Surgical, diathermy
MHRA reference: 2020/001/009/291/002
Siemens Healthcare: Atellica IM & ADVIA Centaur
December 2019
IVDs, clinical chemistry
MHRA reference: 2019/012/023/601/005
Thermo Fisher Scientific Microbiology: Oxoid
30 December 2019
IVDs, bacteriology
Model: PB0298A
MHRA reference: 2019/012/031/601/002
W.L. Gore & Associates: GORE® EXCLUDER® AAA Endoprosthesis & GORE IBE
January 2020
Implants, non active, endoprostheses for aortic aneurysms
MHRA reference: 2019/012/019/291/003