Field Safety Notices: 23 to 27 May 2022

Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 May 2022.

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

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website.

BD: OneFlow

16 May 2022

IVDs, viral microbiology

MHRA reference: 2022/005/024/595/001

Corin: Trinity

13 April 2022

Joint prosthesis, hip

MHRA reference: 2022/004/013/601/001

Gelita Medical: Absorbable Gelatin Sponge Hemostats

22 May 2022

Haemostatic agents

MHRA reference: 2022/005/026/573/001

Haemonetics: TEG 5000 + TEG Manager + TAS + PlateletMapping

09 May 2022

Coagulation

Model: TAS, Platelet Mapping (07-014, 07-015, 07-016)

MHRA reference: 2022/005/020/291/004

Medtronic: MiniMed 640G Insulin Pump (35983); MiniMed 670G Insulin Pump (35983); MiniMed 720G Insulin Pump (64889), MiniMed 740G Insulin Pump (64890); MiniMed 770G Insulin Pump (64891); MiniMed 780G Insulin Pump (64891)

May 2022

Infusion systems

Model: Pump models: MMT-1711, MMT-1712; MMT-1781, MMT-1782; MMT-1809, MMT-1810; MMT-1811, MMT- 1812; MMT-1881, MMT-1882; MMT-1885, MMT-1886. Kit models: MMT-1751, MMT-1752; MMT-1761, MMT- 1762; MMT-1859, MMT-1860; MMT-1861, MMT-1862; MMT-1891, MMT-1892; MMT-1895, MMT-1896.

MHRA reference: 2022/005/026/599/007

Microbiologics: 0801P Clostridium perfringens

05 May 2022

IVDs, bacteriology

Model: KWIK-STIK 0801P

MHRA reference: 2022/005/024/599/002

Molnlycke

16 May 2022

Surgical devices, non-powered

Model: See Product Table

MHRA reference: 2022/005/017/599/001

Ortho Clinical Diagnostics: ORTHO VISION and VISION Max Analyzers for BioVue Cassettes

26 April 2022

IVDs, blood transfusion

Model: 6904579 and 6904578

MHRA reference: 2022/004/022/601/002

Ossur: Vari-Flex Junior

23 May 2022

Prostheses

MHRA reference: 2022/005/024/613/001

Stryker: V40 BIOLOX delta Ceramic Femoral Head

18 March 2022

Joint prosthesis, hip

MHRA reference: 2022/001/027/487/005

Updates to this page

Published 30 May 2022