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

View the 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

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