Field Safety Notices: 17 to 21 May 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 17 to 21 May 2021.
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Anika Therapeutics: Hyalobarrier gel, Hyaloglide gel
May 2021
Surgical tissue adhesive
Model: 130012F, 130035F,130250F,130270F,130280F,130003F,130011F,130021F, 130400F,130500F
MHRA reference: 2021/005/012/701/079
Bard: Venovo Venous Stent System
20 May 2021
Venous Stents
MHRA reference: 2021/005/014/487/018
Becton Dickinson: Venflon Pro IV Cannula
18 May 2021
Cannula Peripheral Iv
MHRA reference: 2021/005/019/487/006
BioPro: Disposable Osteotomes
FSN 21-004
Osteotome
Model: 95-1010, 95-1212, 95-1515C, 95-6006C
MHRA reference: 2021/005/013/601/567
Institut Straumann: SCS Screwdriver for Ratchet, short/long
ER21-0077
Surgical ScrewDriver
Model: 046.401, 046.402
MHRA reference: 2021/005/020/701/016
KARL STORZ: Video Mediastinoscope
May 2021
Endoscopes, Rigid
Model: 10973HD
MHRA reference: 2021/005/014/487/021
Leica Biosystems: BOND Ancillary Products
22 April 2021
Instrumentation/ Platform
Model: BOND Epitope Retrieval 1 AR9961, BOND Epitope Retrieval 2 AR9640 and BOND Wash AR9590
MHRA reference: 2021/005/007/601/545
Lemaitre Vascular: Aortic Occlusion Catheter
07 May 2021
Catheter Occlusion
Model: 2107-80, 2107-81
MHRA reference: 2021/005/014/487/020
Morpheus: REBELLION Punch
06 March 2021
Punch
Model: REB-02-200, REB-02-250
MHRA reference: 2021/005/018/701/017
Nevro: M8 and S8 Lead Adaptors
FAR-000002
Lead adaptor
Model: MADP2008-xx(B); SADP2008-xx(B)
MHRA reference: 2021/005/007/701/024
Quanta System: Sterile Optical fibers
16 April 2021
Laser
Model:
MHRA reference: 2021/004/028/701/027
Scinomed: iPCM Plasma Collection Machine – SPC6+
CAPA36
iPCM Plasma Collection Machine – SPC6+
MHRA reference: 31204516
Siemens Healthcare: Atellica CH 930, IM 1300, IM 1600 Analyzers
May 2021
Reagent/ Assay
Model: Atellica CH 930 Analyzer 11067000, Atellica IM 1300 Analyzer 11066001, Atellica IM 1600 Analyzer 11066000
MHRA reference: 2021/005/018/601/002
Spes Medica: Electrodes and Probe
08 April 2021
Electrode
MHRA reference: 2021/005/019/291/001