Surgical Masks and Respirators (NOT Listed Under MDACS)

Surgical Masks and Respirators (NOT Listed Under MDACS)

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Summary of Safety Alerts

Starting from 1 January 2022, the summary includes some safety alerts related to medical devices not listed under MDACS reported by the trade or overseas authorities. 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 13 July 2022)

Caption: Data Table
Posting Date Description of Product Source of Information *
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. For safety alerts before 1 January 2022, please refer to archive.

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