Surgical Masks and Respirators (NOT Listed Under MDACS)

Surgical Masks and Respirators (NOT Listed Under MDACS)

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Safety Alert Summary

Starting from 1 January 2022, the summary includes some safety alerts related to medical devices not listed under MDACS reported by the trade, other regulatory jurisdictions as well as the World Health Organization. It only serves as a reference and should not be considered as exhaustive and up-to-date information. Please contact manufacturer or local supplier for details. (Updated on 11 March 2024)

Caption: Data Table
Posting Date Description of Product Source of Information *
11 Mar 2024 Bruder Healthcare Company Thermalon Sinus Mask Health Canada
19 Feb 2024 AMD Medicom Inc. HENRY SCHEIN EARLOOP MASKS LEVEL 3 (BLUE) FDA
18 Dec 2023 廣東名立醫療科技有限公司 一次性使用醫用口罩 Guangdong MPA
13 Dec 2023 北京朋來製藥有限公司 醫用防護口罩 Beijing Municipal MPA
27 Nov 2023 廣東同德藥業有限公司 一次性使用醫用口罩 [生産批號: 221106; 涉及産品的型號、規格及批次: 耳掛式 (17.5cm x 9.5cm)] Guangdong MPA
03 Oct 2023 Update: Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication FDA
15 Sep 2023 廣東名立醫療科技有限公司 醫用外科口罩 及 一次性使用醫用口罩 [醫用外科口罩,生産批號:20220802; 一次性使用醫用口罩,生産批號: 20220801; 20220705] Guangdong MPA
11 Sep 2023 Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication FDA
22 Aug 2023 O&M Halyard, Inc FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size Small (Code 46827, Lot #AM2164811) 生產商
18 Aug 2023 東莞市新山科技有限公司 醫用外科口罩 [生産批號:20221025; 涉及產品型號、規格:耳掛式 17.5cm*9.5cm] Guangdong MPA
24 Jul 2023 Med-Con Pty Ltd Surgical face Mask - Earloop Level 3 Barrier [Product Code: 170516; Batch numbers: 45880, 45884, 45889, 45896, 45900, 45903, 45958, 45962, 45968] TGA
19 Jul 2023 Medispec Australia Pty Ltd Mask, Surgical, Single Use TGA
19 Jun 2023 Aidacare Pty Ltd Single use, surgical, mask TGA
22 May 2023 Shengquan (Australia) High-Tech Pty Ltd Shengquan FFP2 Particle Filtering Half Mask; Shengquan KN95 Particle Filtering Half Mask; Unlabelled - Shengquan Respirator TGA
22 May 2023 Advanced Medical Devices (AMD) Pty Ltd Nano-Tech T4 Respirator - All Batches TGA
27 Apr 2023 Guangzhou Biofil Air Purification Materials Co Ltd (Sponsored by Platinum Closing Pty Ltd) Biofil Level 3 Surgical Mask [Batch 202009F01] TGA
13 Apr 2023 Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication FDA
13 Apr 2023 Taxa International Pty Ltd Mask, single use, surgical TGA
13 Apr 2023 Medihealth Guard Facemask Pty Ltd Mask, surgical, single use TGA
13 Apr 2023 Moosh (Australia) Pty Ltd Public respirator, single-use TGA
13 Apr 2023 LYL Investment Pty Ltd Public Respirator, Single use TGA
13 Apr 2023 ASPEN MEDICAL PTY LIMITED Public respirator, single use TGA
13 Apr 2023 Jiangxi Longteng Biological High-Tech Co Ltd (Sponsored by Sunry Health Management Pty Ltd) Mask, surgical, single use TGA
06 Apr 2023 Arya Mobility Pty Ltd Mask, surgical, single use [Batch: 20200318] TGA
04 Apr 2023 Aidacare Pty Ltd Public respirator, single use TGA
27 Mar 2023 AMPEQ Pty Ltd Public face mask, reusable TGA
27 Mar 2023 Life Biotech Pty Ltd Public N95 respirator TGA
27 Mar 2023 Maroon Tree Pty Ltd Mask, surgical, single use; Medical/Surgical Mask TGA
27 Mar 2023 TLC Diagnostics Pty Ltd Mask, surgical, single-use TGA
27 Mar 2023 Big Start Pty Ltd Big Start, Single use surgical mask [Batches: 200730, 200310 & 230320] TGA
16 Mar 2023 Eagle Health Holdings Limited Eagle Health Holdings Ltd mask, surgical, single use TGA
16 Mar 2023 HB Access Pty Ltd HB Access Pty Ltd mask, surgical, single use TGA
14 Mar 2023 Oscar Wylee Pty Ltd mask, single use, surgical TGA
14 Mar 2023 Mednow Pty Ltd mask, surgical, single use TGA
02 Mar 2023 Schiffa Health Pty Ltd Schiffa Health Pty Ltd - mask, surgical, single use TGA
10 Feb 2023 Health One Pty Ltd Health One Surgical Face Mask with Eye Shield Anti-fog, Anti-splash [Batch: S2020-29501, S2020-36501, S2020-36502, S2020-36503; Expiry: 14/08/2025, 30/10/2025, 12/11/2025, 24/11/2025] TGA
06 Jan 2023 EMCHON PTY LTD Medical Surgical Mask TGA
21 Dec 2022 Ironbark Creek Investments KN95 respirators supplied by Ironbark Creek Investments [Product names (as shown on packaging / labelling): Medilogic KN95 Face mask, CX9100 Particulate Mask FFP2 NR, Medilogic KN95 Face mask Box 10, Zhongchen KN95 Face Mask, Zhongchen KN95 Face Mask Non-Surgical, YiHuB KN95 Protective Mask; All batches of the above respirators within expiry] TGA
16 Dec 2022 Orthotic & Prosthetic Centre Pty Ltd OAPL FACE MASK DISPOSABLE 3PLY EARLOOP [Batch number: 205029; Date of manufacture: 05/2020] TGA
13 Dec 2022 Orthotic & Prosthetic Centre Pty Ltd OAPL Protective Face Mask with Earloops KN95 Mask 4PLY EAR LOOP [Batch number: 202004-9] TGA
05 Dec 2022 Mun Global Sdn Bhd PrimeOn Artemis Level 2 Procedure Face Mask w/Earloop - Yellow [Lot number: 2004-09] TGA
30 Nov 2022 BSN Medical (Aust) Pty Ltd Proshield Level 2 & 3 Surgical Masks and Proshield N95 Respirators [Batch numbers: All batches from OCT17; Proshield Resistant Surgical Masks; Batch numbers: All batches from OCT17 with logos only] TGA
18 Aug 2022 Xiantao S&J Protective Products Co Ltd (Sponsored by SWISS MADE BRANDS PTY LTD) D-Touch Disposable Medical Facemasks [All D-Touch Disposable Medical Facemasks manufactured prior to 06-May-2022; D-Touch Disposable Medical Facemask with Elastic Bands, Batch / Expiry: 202003 / Mar-23, 202004 / Apr-23; D-Touch Disposable Medical Facemask with Tie-on, Batch / Expiry: 202010 / Oct-23] TGA
12 Jul 2022 Canggu Medical Tech Co Ltd (Sponsored by PACIFIC HEALTH PTY LTD) Dochem Face Mask and Dochem Face Mask Type IIR [All Batches] TGA
14 Jun 2022 Jiangsu Okam New Materials Ltd KN95/FFP2 Particulate Respirator Mask [Model 516W] Health Canada
06 Jun 2022 Medical Mart Supplies Limited Alliance Earloop Procedure Mask [Lot or serial number: Y591676; Model or catalog number: P703020] Health Canada
26 May 2022 BUNZL Australasia N95 Particulate Respirator N95 FT-N058 [All batches] TGA
10 May 2022 Thai Hospital Products Co Ltd (Sponsored by Thermo Fisher Scientific Australia Pty Ltd) Promed Level 1 surgical face masks with ties, Promed Level 1 surgical face masks with Ear loops [Product reference code: PMD 4501 and PMD 4001; Batch numbers: 16-Sep-20 and 25-Aug-20] TGA
03 May 2022 Mediquip Pty Ltd Gemini Dispoable Surgical Masks [Batch number: 2020072801; Expiry date: 28/07/2022] TGA
03 May 2022 Purist Australian Purist Australian - Mask, medical single use [Batch number: 202003015; Production Date: 17/04/2020] TGA
06 Apr 2022 Omni-Tel Pty Ltd MA-KN95-WOO [Batch numbers: QU201 and QU202; Expiry date: 05/2022 and 06/2022] TGA
30 Mar 2022 MIRATRA PTY LTD GeeeF Disposable Medical Mask [Batch number: 06013; Expiry date: 13/07/2022], Disposable Medical Mask [Batch number: 202004008; Expiry date: 10/06/2022] TGA
30 Mar 2022 MIRATRA PTY LTD Moosh P2 Respirator Mask [Batch Number: 202004008; Expiry Date: 09/2022] TGA
09 Mar 2022 Sichuan Xinglin Medical Device Co Ltd/ Jin Pin Electrical Co Ltd Zhuhai SEZ (Sponsored by Australian Business Mobiles (NSW) Pty Ltd) Beare Medical Face Mask for Single Use - Level 2 Barrier - BMD 2 [Batch number: 26042020 and JP20200606; Expiry date: 30/04/2022 and 31/06/2022] TGA
09 Mar 2022 BSN Medical (Aust) Pty Ltd Proshield Duckbill Fluid Resistant, Proshield Resistant, Proshield Clearview, Proshield Elite Visor Mask, Proshield Elite Antifog Mask, Proshield Elite Pleated Mask and Proshield Super Resistant Antifog Mask [Product codes: 72509-00,72509-04,72509-11,72509-19, 72509-20, 72509-21 and 72509-23; Batch numbers: 26Oct17, 39642 1, 18Sep20, 10Aug17, 29Jun20, 06Oct20 and 14Oct20] TGA
08 Mar 2022 Sentry Medical Pty Ltd OWear Mask with Earloop Fluid Protection IIR-120 mmHg [Batch number: 043020; Expiry date: 1/04/2025] TGA
08 Mar 2022 Pacific Health Pty Ltd Premium Ear-loop-3 Layers Masks [Batch number: WHM-1050] TGA
08 Mar 2022 Sentry Medical Pty Ltd OWear Procedure Mask – Earloop OMK001 Level 2 [Batch number: 12008810F, Expiry date: 31 August 2023] TGA
02 Mar 2022 Arya Mobility Pty Ltd Ripe KN95 Nanofiber filtration Anti-Particulate Anti-virus Mask [Batch number: 2020-03-30] TGA
28 Feb 2022 MCG ELECTRONICS PTY LTD Ripe Doctors KN95 Airway protection face mask TGA
21 Feb 2022 O&M Halyard Australia Pty Ltd Halyard Surgical Mask [Product code 6000; Batch number TH 02161644] & Halyard Procedure Mask [Product code 6001; Batch number TH 00321547] TGA
21 Feb 2022 Icon International Pty Ltd t/a Icon Medipharm 3 PLY DISPOSABLE SURGICAL FACE MASK [Batch number: AL091, Expiry date: 1/3/2025] TGA
15 Feb 2022 Optimed Technologies Pty Ltd Veisha KN95 Mask [Batch number: 20040716] TGA
11 Feb 2022 Southmedic Inc. Clearchoice Foam Face Shields [W84856, W85334, W85588, W85001; SMI3610, SMI3611] Health Canada
04 Feb 2022 Care Essentials Pty Ltd Cocoon Respirator Masks [Regular size head band (MSK-002): *All batches with expiry dates of May 2023 or prior; Small size, ear loop (MSK-001S): *All batches with expiry dates of June 2023 or prior.] TGA
04 Feb 2022 priMED Medical Products Inc PRIMASOFT SURGICAL MASK, TIE, SOFT, WHITE, PG4-2333 Batch: 0419HLP20; PRIMAGARD PROCEDURE MASK, EAR LOOPS, BLUE, PM4-306 Batch: 0426CLP20; PRIMED SURGICAL MASK, TIE, ANTI-FOG, BLUE, PM4-311 Batch: 0523DLP21; PRIMED PEDIATRIC MASK, EARLOOP, DINOSAUR PATTERN, PG4-1680 Batch: 0414HLP20 TGA
04 Feb 2022 Winner Medical Co Ltd (Sponsored by Healthscope Operations PTY LTD) Particulate Respirator FFP2 NR [Batch number: 200519; Expiry date: 31/05/2023] TGA
04 Feb 2022 Healthy Apparel Company Ltd Medical Mask (Adult) [Model or Catalogue Number: ADL2CAGR; Lot or Serial Number: 01L2021A2, 05J2021A2, 09K2021A2, 12J2021A2, 24I2021A2, 18J2021A2, 26J2021A2, 02K2021A2, 17K2021A2, 24K2021A2] Health Canada
31 Jan 2022 Qingdao Santec International Trade Co Ltd (sponsored by Erskine Products Pty Ltd) Piksters Shield Face Masks Level 3 [Batch number: SAN29904A] TGA
31 Jan 2022 St John Ambulance Australia Inc St John Respirator Mask [Batch number: 20200501S0002; Expiry date: 10 May 2023] TGA
21 Jan 2022 A Barcs & Co Nominees Pty Ltd Foldable Protective Earloop Mask KN95 TGA
11 Jan 2022 Bio Protect Bio Protect Disposable Surgical Face Mask 3 Ply with Earloop Level 2 TGA
10 Jan 2022 Mediquip Pty Ltd Gemini KN95 Protective Medical Masks [Batch Number: CY-20200519-1; Expiry Date: 19/05/2022] TGA

 

Special Alerts

Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below.

No record found

 

Note:

* FDA = Food and Drug Administration, United States of America;
  MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
  Health Canada = Health Canada, Canada;
  TGA = Therapeutic Goods Administration, Australia;
  HPRA = Health Products Regulatory Authority, Ireland;
  HSA = Health Sciences Authority, Singapore