Field safety notices - 18 july - 22 july 2016
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FIELD SAFETY NOTICES - 18 JULY - 22 JULY 2016 Summary List of field safety notices (FSNs) from medical device manufacturers from 18 - 22 July 2016 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 APTISSEN: HEALAFLOW 26 June 2016 Implants, non-active, intraocular Model: A-HEA-060 MHRA reference: 2016/007/005/291/010 DEPUY SYNTHES: PART NUMBER 412.812 -
LOCKING SCREW STARDRIVE® Ø 2.4 MM, SELF-TAPPING, LENGTH 12 MM, TITANIUM ALLOY (TAN) ; PART NUMBER 412.812S - LOCKING SCREW STARDRIVE® Ø 2.4 MM, SELF-TAPPING, LENGTH 12 MM, TITANIUM ALLOY
(TAN), STERILE 15 July 2016 Osteosynthesis, bone screws Model: 412.812 & 412.812S MHRA reference: 2016/007/019/299/017 DIASORIN: LLAISON® ESTRADIOL II GEN 13 July 2016 IVDs, clinical
chemistry MHRA reference: 2016/007/015/291/001 GAMBRO DASCO: ARTIS 230V 20 July 2016 Dialysis, haemodialysis Model: 110635 MHRA reference: 2015/007/023/701/010 HOWMEDICA OSTEONICS: TRIATHLON
RA 2016-077 Orthopaedic Surgical instruments Model: Triathlon Modular Handle MHRA reference: 2016/007/012/291/015 MACOPHARMA: NPT6280LA / WHOLE BLOOD COLLECTION SET 20 July 2016 Infusion
& transfusion, blood bags MHRA reference: 2016/006/030/291/004 ORTHO CLINICAL DIAGNOSTICS: VITROS ESTRADIOL REAGENT PACK July 2016 IVDs, clinical chemistry MHRA reference:
2016/007/015/601/005 PHILIPS: MULTIDIAGNOST ELEVA, URODIAGNOST, MULTIDIAGNOST ELEVA WITH FLAT DETECTOR 8 July 2016 X Ray, fluoroscopy systems Model: 708032 708033 708034 708036 708037 708038
MHRA reference: 2016/007/020/291/012 SHENZHEN MINDRAY BIO-MEDICAL:THE BENEVISION N22 AND N19 PATIENT MONITORS June 2016 Monitors, patient MHRA reference: 2016/007/004/701/020 STRYKER:
TRIDENT CONSTRAINED LINER IMPACTOR TIPS RA 2015-181 Orthopaedic surgical instruments - Impacting tools MHRA reference: 2016/006/030/291/005 SYSMEX: FLUOROCELL PLT 19 July 2016 IVDs,
Haematology MHRA reference: 2016/006/001/299/005 TRIVIDIA: TRUERESULT (PQQ), TRUETRACK TEST STRIPS 19 July 2016 IVDs, self / home testing MHRA reference: 2016/007/020/291/015 XIROS:
INFINITY-LOCK 18 July 2016 Ligaments, tendons and anchors Model: 102-1088 MHRA reference: 2016/007/018/601/001 UPDATES TO THIS PAGE Published 25 July 2016