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Field Safety Notices

Field Safety Notice - Jan 2020

31 January 2020

Audiences

Healthcare professional

Industry member

Product-type

Medical devices

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Date of Notification	Title	FSN
3 Jan 2020	PDS Plus Antibacterial Sutures, Ethicon, LLC (HSA 600:41/01-002/20/02_62) Local Contact: Johnson & Johnson Pte Ltd Contact No./Email: 6918 8000 / RA-ITSUS-JJMSingapo@ITS.JNJ.COM	HSA 6004101-002-20-02_62 FSN [PDF, 67 KB] (opens in new tab)
3 Jan 2020	Strykeprobe Sheath, Stryker Endoscopy (HSA600:41/01-014/20/01_82) Local Contact: Stryker Singapore Pte Ltd Contact No./Email: 6662 5912 / asean.pms@stryker.com	HSA 6004101-014-20-01_82 FSN [PDF, 336 KB] (opens in new tab)
3 Jan 2020	O-arm O2 Imaging System, Medtronic Navigation, Inc (Littleton) (HSA 600:41/01-009/20/01_80) Local Contact: Medtronic International Ltd Contact No./Email: 6436 5000	HSA 6004101-009-20-01_80 FSN [PDF, 286 KB] (opens in new tab)
2 Jan 2020	Stryker CORE Footswitch, Stryker Instruments (HSA 600:41/01-014/19/11_44) Local Contact: Stryker Singapore Pte Ltd Contact No./Email: asean.pms@stryker.com	HSA 6004101-014-19-11_44 FSN [PDF, 347 KB] (opens in new tab)
2 Jan 2020	VITROS® Chemistry Products Calibrator Kit 2, Ortho-Clinical Diagnostic (HSA 600:41/01-303/19/10_89) Local Contact: ORTHO-Clinical Diagnostics Singapore Pte. Ltd Contact No./Email: 6486 1151	HSA 6004101-303-19-10_89 FSN [PDF, 224 KB] (opens in new tab)
2 Jan 2020	Synthes VA LCP Two-Column Distal Radius Plate System (Trauma Sterile Tube, M size), Synthes GmbH (HSA 600:41/01-002/20/01_48) Local Contact: Johnson & Johnson Pte Ltd Contact No./Email: 6918 8000 / RA-ITSUS-JJMSingapo@ITS.JNJ.COM	HSA 6004101-002-20-01_48 FSN [PDF, 407 KB] (opens in new tab)
2 Jan 2020	Elecsys Troponin T hs, Roche Diagnostics GmbH (HSA 600:41/01-016/19/28_92) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact No./Email: sg.regulatory@roche.com	HSA 6004101-016-19-28_92 FSN [PDF, 1716 KB] (opens in new tab)
15 Aug 2019	Concerto / Basic Shower Trolley, ArjoHuntleigh AB (HSA 6004101-065-19-02_66 FSN) Local Contact: Arjo South East Asia Pte. Ltd. Contact No./Email: 6202 7366 / singapore@arjo.com	HSA 6004101-065-19-02_66 FSN [PDF, 283 KB] (opens in new tab) This updated FSN replaces the original FSN published in Aug 2019.
20 June 2018	Maestro 4000 Cardiac Ablation System Optional Foot Switch, Boston Scientific Corporation (HSA 600:41/01-007/18/04_63) Local Contact: Boston Scientific Asia Pacific Pte Ltd Contact No./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com	HSA 6004101-007-18-04_63 FSN [PDF, 375 KB] (opens in new tab) This FSN is an update to the original FSN published in June 2018.