Field Safety Notices: 14 to 18 September 2020
List of Field Safety Notices (FSNs) from medical device manufacturers from 14 September to 18 September 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.
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Bard: Bard庐 PowerMidline鈩� 3F SL (single-lumen) kits
09 September 2020
Vascular cannula and catheters
MHRA reference:
Baxter: WRO 300H Water Purification System
14 September 2020
Dialysis, haemodialysis
Model: 955686
MHRA reference:
Beckman Coulter: Access Unconjugated Estriol
14 September 2020
IVDs, clinical chemistry
MHRA reference:
Blink Medical: HR620: Cannula Liposuction 30cm x 6mm,
HR621: Cannula Liposuction 30cm x 5mm, HR622: Cannula Liposuction 30cm x 4mm, HR623: Cannula Liposuction 30cm x 3mm, HR624: Cannula Liposuction 15cm x 4mm, HR625: Cannula Liposuction 15cm x 3mm, HR626: Cannula Liposuction 15cm x 2mm
09 September 2020
Surgical instruments, minimal access
Model: HR620; HR621; HR622; HR623; HR624; HR625; and HR626
MHRA reference:
Boston Scientific: Hurricane RX Biliary Balloon Dilatation Catheter
92583333-FA
Surgical instruments, minimal access
MHRA reference:
Brainlab: Ultrasound Navigation Software
31 August 2020
Surgical navigation system and accessories
Model: 22582; 22582A; 22582B; 22583; 26506; 26506A; 26508A
MHRA reference:
Coloplast: ELEFANT庐 Suction/irigation device
14 September 2020
Surgical equipment, miscellaneous
Model: 64120
MHRA reference:
Draeger: Perseus A500
September 2020
Anaesthetic machines & monitors
Model: Perseus A500, MK06000
MHRA reference:
Exactech: Compression Screw/Locking Cap Kits
08 September 2020
Osteosynthesis, bone screws
MHRA reference:
Mentor: MENTOR庐 Breast Tissue Expander
2 September 2020
Implants, tissue expanders
Model: CPX4
MHRA reference:
Merit Medical: Prelude SNAP鈩�; Worley鈩�,
1721504-08/31/20-005R
Vascular cannula and catheters
MHRA reference:
Smith & Nephew: Suture Base Repair Systems
11 September 2020
ligaments, tendons and anchors
MHRA reference:
Steripack: Syringe 10 ml with 0,9% sodium chloride
21 August 2020
Vascular cannula/catheter accessories
MHRA reference:
Welland Medical: Hydroframe with Manuka Honey
09 September 2020
Wound management
Model: (X)MHWAFH33
MHRA reference: