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: