Field safety notices - 15 to 19 February 2016
List of field safety notices (FSNs) from medical device manufacturers from 15 February to 19 February 2016
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
FA2015-52
Surgical iInstruments, minimal access
Model: Bard TruGuide® Disposable Coaxial Biopsy Needle, C2016B
MHRA reference: 2016/002/015/601/005
Becton, Dickinson & Company: BD Surepath Preservative Collection Vial
15 February 2016.
IVDs, cytopathology & histopathology
Model: 490527; 490505; 491288
MHRA reference: 2016/002/016/601/008
Caesarea Medical Electronics: CME BodyGuard Infusion Sets
09 February 2016
Infusion & transfusion, administration sets
Model: 120-112XSFV, 100-163XESK, 120-112XSFK, 100-163XE90SK,
MHRA reference : 2016/002/017/291/001
Eli Lilly and Company: Filter kit provided free of charge with ReoPro
12 February 2015
Infusion & transfusion, administration sets
MHRA reference: 2016/002/015/292/011
GE Healthcare Life Sciences: Carestation 620 A1 / 650 A1 / 650c A1
FMI34074 Anaesthetic machines & monitors MHRA reference: 2016/002/011/292/002
RaySearch Laboratories
9397 Radiotherapy planning and verification systems Model: 3.0, 3.5, 4.0, 4.5 and 4.7
MHRA reference: 2016/002/012/701/010
Teleflex: Hem-o-lok Auto Endo5 Medium Large Ligating Clip Applier
12 February 2016
Endoscopic single clip applier
Model: 543965, WK543965
MHRA reference: 2016/002/015/291/007
Verathon Medical: GlideScope® Video Laryngoscope Titanium SU blades
09 February 2016
Airway devices MHRA reference: 2016/002/015/291/002
Verathon Medical:
09 February 2016
Airway devices
Model: LoPro S3: 0574-0130 (single blade), LoPro S4: 0574-0131 (single blade), MAC S3: 0574-0132 (single blade), MAC S4: 0574-0133 (single blade)
MHRA reference: 2016/002/012/292/007