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
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Anika Therapeutics: Hyalobarrier gel, Hyaloglide gel
May 2021
Surgical tissue adhesive
Model: 130012F, 130035F,130250F,130270F,130280F,130003F,130011F,130021F, 130400F,130500F
MHRA reference:
Bard: Venovo Venous Stent System
20 May 2021
Venous Stents
MHRA reference:
Becton Dickinson: Venflon Pro IV Cannula
18 May 2021
Cannula Peripheral Iv
MHRA reference:
BioPro: Disposable Osteotomes
FSN 21-004
Osteotome
Model: 95-1010, 95-1212, 95-1515C, 95-6006C
MHRA reference:
Institut Straumann: SCS Screwdriver for Ratchet, short/long
ER21-0077
Surgical ScrewDriver
Model: 046.401, 046.402
MHRA reference:
KARL STORZ: Video Mediastinoscope
May 2021
Endoscopes, Rigid
Model: 10973HD
MHRA reference:
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:
Lemaitre Vascular: Aortic Occlusion Catheter
07 May 2021
Catheter Occlusion
Model: 2107-80, 2107-81
MHRA reference:
Morpheus: REBELLION Punch
06 March 2021
Punch
Model: REB-02-200, REB-02-250
MHRA reference:
Nevro: M8 and S8 Lead Adaptors
FAR-000002
Lead adaptor
Model: MADP2008-xx(B); SADP2008-xx(B)
MHRA reference:
Quanta System: Sterile Optical fibers
16 April 2021
Laser
Model:
MHRA reference:
Scinomed: iPCM Plasma Collection Machine 鈥� SPC6+
CAPA36
iPCM Plasma Collection Machine 鈥� SPC6+
MHRA reference:
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:
Spes Medica: Electrodes and Probe
08 April 2021
Electrode
MHRA reference: