Field safety notices - 12 to 16 October 2015
List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 October 2015.
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
Alere Connected Health: ImmunoComb® II HIV 1&2 Bispot
25 August 2015
IVDs, viral microbiology
MHRA reference: 2015/009/003/292/007
B Braun Avitum AG: single - needle-adapter ETO
14 October 2015
Dialysis, blood lines
Model: 7210868
MHRA reference: 2015/010/014/601/014
Bridge to Life: Belzer UW(R) Cold Storage Solution
7 October 2015
Storage and collection devices
MHRA reference: 2015/010/009/601/013
CareFusion: Alaris® Pump Model
October 2015
Infusion systems
Model: 8110
MHRA reference: 2015/010/006/299/002
Coloplast: Testicular Implant (35277) and Vaginal Stent (35646)
9 October 2015
Implants, Reconstructive, Body Contouring
Model: R3001, PR3002, PR3003, PR3004, PR3005, VS3020, VS3022, VS3024 and VS3026
MHRA reference: 2015/010/009/299/003
Cook Medical: Beacon Tip Angiographic Catheters
8 October 2015
Vascular cannula and catheters
MHRA reference: 2015/007/013/291/011
Dräger Medical:
June 2015
Anaesthetic machines & monitors
Model: Fabius MRI
MHRA reference: 2015/006/016/291/001
eVent Medical: Inspiration Ventilatory System
12 October 2015
Lung ventilators
MHRA reference: 2015/010/005/292/004
Galil Medical: IceRod 1.5 PLUS Cryoablation Needle
6 October 2015
Surgical, cryogenic
Model: FPRPR 3508
MHRA reference: 2015/010/012/601/015
Hospira UK: Plum 360 Infusion Pump
14 October 2015
Infusion systems
Model: Attached
MHRA reference: 2015/010/009/051/003
Johnson & Johnson: PowerStar Bipolar Cable
30 September 2015
Infusion systems
MHRA reference: 2015/010/008/292/015
MAQUET Cardiopulmonary AG: Heater Cooler Unit 30
13 October 2015
Infusion & Transfusion, heart lung circuits
Model: Heater-Cooler Unit 30 with Serial Number <93101480, HCU 30 Base Unit 100-120 V, article number 704629 / 70103.4371 HCU 30 base unit 200 - 240 V, article number 704631 / 70103.4642 HCU 30 base unit Canadian/US, article number 705501 / 70103.4653
MHRA reference: 2015/010/015/292/003
Philips Medical: Allura Xper
FCO72200324
X Ray, fluoroscopy systems
Model: 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 72205
MHRA reference: 2015/010/013/292/019
Riverside Medical Packaging Company
1 October 2015
Infusion and transfusion, administration sets
Model: Aseptic Medical Devices (AMD) Sterile Compounding Procedure Packs, S10A03A, S25A03A, SING001, S05A05A, S10A05A, S25A05A, STTH001, DERR001, STTH002
MHRA reference: 2015/010/001/601/003
Siemens Healthcare Diagnostics: ADVIA Chemistry XPT System
October 2015
IVDs, clinical chemistry
Model: SMN 10723034
MHRA reference: 2015/010/013/601/007
Stryker Orthopaedics-Mahwah: MIS Distal Captures
October 2015
Surgical Instruments, Implant
Model: MIS Distal Captures 6541-5-723
MHRA reference: 2015/010/015/292/001
Thermo Fisher: Oxoid™ M.I.C.Evaluator™ (M.I.C.E.™)
October 2015
Oxoid™ M.I.C.Evaluator™ (M.I.C.E.™) (MA0101D/F Penicillin 256μg/ml )
IVDs, bacteriology
MHRA reference: 2015/010/014/601/016
Tornier: Radial Head Prosthesis
13 October 2015
Joint Prosthesis, elbow
Model: Radial Head Prosthesis
MHRA reference: 2015/010/014/291/001
Ventana Medical: Virtuoso software version 5.4 and 5.5 Image Measurement issue
7 October 2015
IVDs, cytopathology & histopathology
Model: catalogue number: 07299303001(v5.4), 07073984001(v5.5)
MHRA reference: 2015/010/013/292/004
Wescott Medical: Wescott
9 October 2015
Infusion & transfusion, administration sets
Model: WEARY-2
MHRA reference: 2015/010/009/601/017