Field Safety Notices
Field Safety Notice - Oct 2017
31 October 2017
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
27 Oct 2017 | ETHICON VICRYL RAPIDE™ SUTURE, ENDOLOOP® Coated VICRYL® SUTURE, and ENDOLOOP® PDS® II SUTURE, Ethicon LLC, Ethicon Inc (HSA 600:41/01-002/17/14_56) | HSA 6004101-002-17-14_56 FSN [PDF, 2836 KB] (opens in new tab) |
27 Oct 2017 | Alinity s System Abbott, GmbH & Co. Kg (HSA 600:41/01-005/17/20_58) | HSA 60041-01-005-17-20_58 FSN [PDF, 16 KB] (opens in new tab) |
27 Oct 2017 | ACETABULAR CUP INTRODUCER (32mm), DePuy International (HSA 600:41/01-002/17/13_46) | HSA 6004101-002-17-13_46_FSN_Redacted [PDF, 201 KB] (opens in new tab) |
26 Oct 2017 | Alinity s System, Abbott GmbH & Co. KG (HSA 600:41/01-005/17/19_59) | HSA 6004101-005-17-19_59 FSN [PDF, 99 KB] (opens in new tab) |
26 Oct 2017 | A.L.P.S Minimally-Invasive (MIS) and Mesh Calcaneus Plating System, Biomet Orthopaedics (HSA 600:41/01-008/17/16_63) | HSA 6004101-008-17-16_63 FSN_Redacted [PDF, 86 KB] (opens in new tab) |
25 Oct 2017 | COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4; COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3, Smith & Nephew Inc. (HSA 600:41/01-073/17/15_44) | HSA 6004101-073-17-15_44 FSN [PDF, 117 KB] (opens in new tab) |
25 Oct 2017 | Néoplastine CI Plus 2 (ref. 00374), Néoplastine CI Plus 5 (ref. 00375), STA-Néoplastine CI 5 (ref. 00605) and STA -Néoplastine CI Plus 5 (ref. 00606), Diagnostica Stago S.A.S (HSA 600:41/01-137/17/04_38) | HSA 6004101-137-17-04_38_FSN (pg1)_Redacted [PDF, 409 KB] (opens in new tab) |
25 Oct 2017 | Trigen Intertan 10s 10mm x 18cm (130), Smith & Nephew Inc. (HSA 600:41/01-073/17/16_25) | HSA 6004101-073-17-16_25_FSN [PDF, 173 KB] (opens in new tab) |
24 Oct 2017 | Sorin Stockert S5 System, Sorin Group Deutschland GmbH (HSA 600:41/01-299/17/02_54) | HSA 6004101-299-17-02_54 FSN_Redacted [PDF, 46 KB] (opens in new tab) |
24 Oct 2017 | rHead Radial Head and Uni-Elbow, Stryker GmbH (HSA 600:41/01-226/17/01_52) | HSA 6004101-226-17-01_52_FSN [PDF, 197 KB] (opens in new tab) |
23 Oct 2017 | ACUVUE® OASYS® and ACUVUE® OASYS® for Astigmatism, Johnson & Johnson Vision Care Inc. (HSA 600:41/01-002/17/12_43) | HSA 6004101-002-17-12_43 FSN [PDF, 505 KB] (opens in new tab) |
20 Oct 2017 | BD PhaSeal Secondary Set, Becton, Dickinson and Company (BD) (HSA 600:41/01-003/17/20_48) | HSA 6004101-003-17-20_48 FSN [PDF, 159 KB] (opens in new tab) |
19 Oct 2017 | Stryker® Navigation Thoracic Pedicle Feeler, Stryker Leibinger GmbH & Co. KG (HSA 600:41/01-014/17/06_64) | HSA 6004101-014-17-06_64 FSN [PDF, 173 KB] (opens in new tab) |
19 Oct 2017 | TunneLoc Tibial Fixation Devices, Biomet Orthopaedics (HSA 600:41/01-008/17/15_63) | HSA 6004101-008-17-15_63 FSN [PDF, 66 KB] (opens in new tab) |
17 Oct 2017 | WECK® Auto Endo5® Automatic Hem-o-lok® Clip Appliers, Teleflex Medical US (HSA 600:41/01-139/17/04_500) | HSA 6004101-139-17-04_50 FSN_Redacted [PDF, 192 KB] (opens in new tab) |
16 Oct 2017 | Alinity i Processing Module, Abbott Laboratories (HSA 600:41/01-005/17/18_34) | HSA 6004101-005-17-18_34 FSN [PDF, 89 KB] (opens in new tab) |
13 Oct 2017 | VITEK® 2 Gram-Positive (GP) Identification (ID) Test Kit, bioMérieux, Inc. (HSA 600:41/01-146/17/11_69) | HSA 6004101-146-17-11_69 FSN [PDF, 833 KB] (opens in new tab) |
12 Oct 2017 | TRIGEN LOW PROFILE SCREW 5.0MM X 65MM, Smith & Nephew Inc. (HSA 600:41/01-073/17/14_43) | HSA 6004101-073-17-14_43 FSN [PDF, 174 KB] (opens in new tab) |
12 Oct 2017 | Alinity hq Analyzer, Abbott GmbH & Co (HSA 600:41/01-005/17/17_67) | HSA 6004101-005-17-17_67 FSN [PDF, 95 KB] (opens in new tab) |
11 Oct 2017 | Bard Atlas Gold PTA Dilatation Catheter, Bard Peripheral Vascular, Inc (HSA 600:41/01-050/17/03_35) | HSA 6004101-050-17-03_35 FSN_Redacted [PDF, 90 KB] (opens in new tab) |
11 Oct 2017 | Carestation 620, 650 and 650c, Datex-Ohmeda, Inc (HSA 600:41/01-010/17/05_44) | HSA 6004101-010-17-05_44 FSN_Redacted [PDF, 288 KB] (opens in new tab) |
09 Oct 2017 | Medtronic FlexCath Advance™ Steerable Sheath, Medtronic CryoCath LP(HSA 600:41/01-009/17/21_36) | HSA 6004101-009-17-21_36 FSN_Redacted [PDF, 1893 KB] (opens in new tab) |
09 Oct 2017 | Sirus Drill Trauma Instrument and Flexible Shaft Hip & Anatomical Shoulder Instrument, Zimmer GmbH (HSA 600:41/01-008/17/14_62) | HSA 6004101-008-17-14_62 FSN [PDF, 61 KB] (opens in new tab) |
09 Oct 2017 | Alinity i Processing Module & Alinity ci series system control module (SCM), Abbott Laboratories (HSA 600:41/01-005/17/16_61) | HSA 6004101-005-17-16_61 FSN [PDF, 234 KB] (opens in new tab) |
05 Oct 2017 | Vibrio cholerae Inaba 2ml/VL, Remel Europe Limited (HSA 600:41/01-178/17/06_60) | HSA 6004101-178_17-06_60 FSN_Redacted [PDF, 360 KB] (opens in new tab) |
05 Oct 2017 | Anaconda AAA Stent Graft System, Vascutek Ltd (HSA 600:41/01-028/17/02_35) | HSA 6004101-028-17-02_35 FSN_Redacted [PDF, 196 KB] (opens in new tab) |
05 Oct 2017 | BD™ FC Beads 7‐Color Kit, Becton, Dickinson and Company (BD) (HSA 600:41/01-003/17/19_38) | HSA 6004101-003-17-19_38 FSN_Redacted [PDF, 805 KB] (opens in new tab) |
05 Oct 2017 | Bio-Rad DiaMed ID-Card LISS/Coombs, DiaMed GmbH (HSA 600:41/01-027/17/08_58) | HSA 6004101-027-17-08_58 FSN pg1_Redacted [PDF, 2573 KB] (opens in new tab) |
03 Oct 2017 | DiaMed QC System, DiaMed GmbH (HSA 600:41/01-027/17/07_69) | HSA 6004101-027-17-07_69 FSN_Redacted [PDF, 2808 KB] (opens in new tab) |
03 Oct 2017 | ARCHITECT c4000, c8000, c16000, Abbott Laboratories (HSA 600:41/01-005/17/15_67) | HSA 6004101-005-17-15_67 FSN [PDF, 112 KB] (opens in new tab) |
03 Oct 2017 | Philips Intellivue Information Center IX and Informationi Center Classic, Philips Medical Systems (HSA 600:41/01-026/17/17_37) | HSA 6004101-026_17-17_37 FSN_Redacted [PDF, 110 KB] (opens in new tab) |
02 Oct 2017 | Pilling Knife Handles, Teleflex Medical (US) (HSA 600:41/01-139/17/03_19) | HSA 6004101-139-17-03_19 FSN_Redacted [PDF, 202 KB] (opens in new tab) |
02 Oct 2017 | Vanguard CR Tibial Bearing and the Vanguard CR Lipped Tibial Bearing, Biomet Othopaedics (HSA 600:41/01-008/17/13_36) | HSA 6004101-008-17-13_36 FSN [PDF, 207 KB] (opens in new tab) |
02 Oct 2017 | Medtronic O-arm O2 Imaging System, Medtronic Nagivation, Inc (HSA 600:41/01-009/17/20_25) | HSA 6004101-009-17-20_25_FSN_Redacted [PDF, 42 KB] (opens in new tab) |
02 Oct 2017 | Da Vinci Xi EndoWrist Stapler 45 Clutch Spindle, Intuitive Surgical, Inc (HSA 600:41/01-070/17/17_37) | HSA 6004101-070-17-17_37 FSN [PDF, 605 KB] (opens in new tab) |
26 Oct 2016 | Nellix EndoVascular Aneurysm Sealing System (Nellix System), Endologix, Inc. (HSA 600:41/01-057/16/05_54) | HSA 6004101-057-16-05_54 FSN_updated_Redacted [PDF, 867 KB] (opens in new tab) |