Field Safety Notice: 20 to 24 January 2020

List of field safety notices (FSNs) from medical device manufacturers from 20 January to 24 January 2020

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

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AVANOS Medical: HALYARD* CLOSED SUCTION SYSTEM FOR NEONATES

30 December 2019 Airway suction equipment MHRA reference:

Biomet: CERTAIN BELLATEK ENCODE HEALING ABUTMENT

January 2020 Implants, dental MHRA reference:

CardinalHealth: Code: 11832215 Monoject鈩� 3ml Syringe with Safety Needle, 21G x 1-1/2鈥� (0.813mm x 3.8cm), Class IIa, GMDN: 59230 鈥� Hypodermic needle, sterile, single use

Code: 1183005 Monoject鈩� Safety Needle, 30G x 1/2鈥� (0.305 mm x 1.3 cm) IIa, GMDN: 59230 鈥� Hypodermic Needle, Single Use, Sterile Code: 1182558 Monoject鈩� Safety Needle, 25G x 5/8鈥� (0.508 mm x 1.6 cm), Class IIa, GMDN: 59230 鈥� Hypodermic Needle, Single Use, Sterile Code: 11811022F Monoject鈩� Bluntfill with Filter, 18G x 1-1/2鈥� (1.27 mm x 3.8 cm), Class I, GMDN: 16266 鈥� Medication Transfer Needle, Filtering

15 January 2020 Injection devices Model: 11832215, 1183005, 1182558, 11811022F MHRA reference:

Depuy Synthes: SPECIALIST庐 2 DISTAL FEMORAL CUTTING BLOCK

03 January 2020 Orthopaedic surgical instruments - Insertion/extraction tools Model: 966115 MHRA reference:

FCI S.A.S.: Huile silicone purifi茅e

13 December 2019 Injection devices MHRA reference:

Hologic: Selenia Dimensions Mammography System

22 January 2020 Mammography MHRA reference:

LiNA Medical (Stryker): Telescopic Smoke Evacuation Pencil

16 January 2020 Surgical, diathermy MHRA reference:

LINET: Eleganza 5

22 November 2019 Beds and accessories MHRA reference:

Mavidon Medical

28 December 2019 ECG Model: Gel MHRA reference:

Merivaara: Practico145000

14 January 2020 Operating table MHRA reference:

Sedana Medical: AnaConDa-S

22 January 2020 Anaesthetic machines & monitors MHRA reference:

SenoRx, (Bard): EnCor庐 Breast Biopsy Probe

16 January 2020 Mammography MHRA reference:

Siemens Healthcare Diagnostics: Atellica CH Reaction Cuvette Segment

January 2020 IVDs, clinical chemistry MHRA reference:

Updates to this page

Published 27 January 2020