Field Safety Notices
Field Safety Notice - Oct 2017
Audiences
Healthcare professional
Industry member
Product type
Medical devices
31 October 2017
This article has been migrated from an earlier version of the site and may display formatting inconsistencies.
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) |