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
View the latest FSNs
AVANOS Medical: HALYARD* CLOSED SUCTION SYSTEM FOR NEONATES
30 December 2019 Airway suction equipment MHRA reference: 2019/011/015/291/004
Biomet: CERTAIN BELLATEK ENCODE HEALING ABUTMENT
January 2020 Implants, dental MHRA reference: 2020/001/016/487/016
CardinalHealth: Code: 11832215 Monoject™ 3ml Syringe with Safety Needle, 21G x 1-1/2” (0.813mm x 3.8cm), Class IIa, GMDN: 59230 – Hypodermic needle, sterile, single use
Code: 1183005 Monoject™ Safety Needle, 30G x 1/2” (0.305 mm x 1.3 cm) IIa, GMDN: 59230 – Hypodermic Needle, Single Use, Sterile Code: 1182558 Monoject™ Safety Needle, 25G x 5/8” (0.508 mm x 1.6 cm), Class IIa, GMDN: 59230 – Hypodermic Needle, Single Use, Sterile Code: 11811022F Monoject™ Bluntfill with Filter, 18G x 1-1/2” (1.27 mm x 3.8 cm), Class I, GMDN: 16266 – Medication Transfer Needle, Filtering
15 January 2020 Injection devices Model: 11832215, 1183005, 1182558, 11811022F MHRA reference: 2020/001/017/291/001
Depuy Synthes: SPECIALIST® 2 DISTAL FEMORAL CUTTING BLOCK
03 January 2020 Orthopaedic surgical instruments - Insertion/extraction tools Model: 966115 MHRA reference: 2020/001/007/291/020
FCI S.A.S.: Huile silicone purifiée
13 December 2019 Injection devices MHRA reference: 2020/001/021/487/001
Hologic: Selenia Dimensions Mammography System
22 January 2020 Mammography MHRA reference: 2020/001/022/601/003
LiNA Medical (Stryker): Telescopic Smoke Evacuation Pencil
16 January 2020 Surgical, diathermy MHRA reference: 2020/001/016/487/014
LINET: Eleganza 5
22 November 2019 Beds and accessories MHRA reference: 2019/012/020/291/001
Mavidon Medical
28 December 2019 ECG Model: Gel MHRA reference: 2020/001/007/228/002
Merivaara: Practico145000
14 January 2020 Operating table MHRA reference: 2020/001/021/487/002
Sedana Medical: AnaConDa-S
22 January 2020 Anaesthetic machines & monitors MHRA reference: 2020/001/024/291/001
SenoRx, (Bard): EnCor® Breast Biopsy Probe
16 January 2020 Mammography MHRA reference: 2020/001/020/291/001
Siemens Healthcare Diagnostics: Atellica CH Reaction Cuvette Segment
January 2020 IVDs, clinical chemistry MHRA reference: 2020/001/020/601/007