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 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