Field safety notices - 17 - 21 October 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 17 - 21 October
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
Bard: X-Force™ Nephrostomy Balloon Dilation Catheter Kit
FA2016-42
Urinary catheters and accessories
MHRA reference: 2016/010/019/601/009
Baylis Medical: NRG Transseptal Needle
17 October 2016
Vascular cannula/catheter accessories
MHRA reference: 2016/010/018/291/003
Cellnovo: Cellnovo
18 October 2016
Infusion systems
Model: 2000054, 2000055
MHRA reference: 2016/010/007/601/010
Endolologix: Nellix, Endovascular Aneurysm Sealing System
18 October 2016
Implants, non-active, endoprostheses for aortic aneurysms
Model: N10-100, N10-110, N10-120, N10-130, N10-140, N10-150, N10-160, N10-170, N10-180, N10-190, N10-200, NP-002; NP-001; NP-003; NP-005; NX-001, NX-002a
MHRA reference: 2016/010/020/601/004
Inpeco: FlexLab
October 2016
IVDs, clinical chemistry
MHRA reference: 2016/010/005/291/012
Lumenis: FemTouch™ Kit and FemTouch™ Tip
25 September 2016
Therapy, lasers
MHRA reference: 2016/010/019/291/008
Medtronic: Charging System, RestoreSensor Charging System
October 2016
Implants, active, leads, neuro
Model: 37651, 37754 and 97754 (containing the model 37751 recharger)
MHRA reference: 2016/010/018/131/004
Neovasc: Neovasc Reducer Kit
FCA 16-001-R
Implants, non-active, coronary artery stents
Model: RED-001
MHRA reference: 2016/010/013/601/007
Newdeal: Drill dia. 1.9mm
14 October 2016
Surgical power tools
Model: 119618
MHRA reference: 2016/010/014/299/008
Ortho Clinical: VITROS Immunodiagnostic Products Intact PTH
October 2016
IVDs, clinical chemistry
Model: 680 2892
MHRA reference: 2016/010/014/601/009
RaySearch Laboratories: RayStation
11 October 2016
Radiotherapy planning and verification systems
Model: 5.0
MHRA reference: 2016/010/013/701/014
Roche: GLU/LAC/UREA (BUN) Cassette
12 October 2016
IVDs, extra laboratory testing
MHRA reference: 2016/010/017/701/011
Shermond: PremierBand/Shermond
13 October 2016
Bandages and tapes
Model: PM1976; PM1974; PM1970
MHRA reference: 2016/010/014/291/014
Siemens: ADVIA Centaur CA 19-9
October 2016
ADVIA centaur ca 19-9
Model: 10491244 (1-pack); 10491379(5-pack)
MHRA reference: 2016/010/020/601/006
Sorin: PLATINIUM
05 October 2016
Implants, active, defibrillators
Model: PLATINIUM VR 1210
PLATINIUM DR 1510, PLATINIUM CRT-D 1711, PLATINIUM SonR CRT-D 1811, PLATINIUM VR 1240, PLATINIUM DR 1540, PLATINIUM CRT-D 1741, PLATINIUM SonR CRT-D 1841
MHRA reference: 2016/008/023/299/011
Synthes: FACET WEDGE
13 October 2016
Spinal implants
Model: 04.630.130S, 04.630.131S, 04.630.132S, 04.630.135.02S.
MHRA reference: 2016/010/014/701/012
Synthes: SynReam Reaming Rod ø 2.5mm, L 650mm
12 October 2016
Surgical instruments, non-articulated cutting
Model: 351.709S351.709S
MHRA reference: 2016/010/014/701/013
Ultroid: Ultroid Hemorrhoid Management System (UHMS) Device kits, Procedure Packs, and individual replacement parts
05 October 2016
Surgical, diathermy
MHRA reference: 2016/010/006/299/004