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Urgent Field Safety Notice - Keep/KeepSafe Mask

https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2021/03/4n-health-oy-ltd-informerer-om-yderligerere-test-og-opdatering-af-vejledningen-for-keep-og-keepsafe-masker/

FSCA-1
Information regarding Instructions for Use supplied with Keep masks Date: 3.3.2021 
Attention: Distributors and Users
Affected products: Keep/Keep Safe surgical mask: sizes: S/M, M/L, Kids, grey or black LOT: AZ001/07/2020
Description of the problem: The mask is functioning as intended, but a need for additional testing and more clear labelling was identified during inspection.
The label instruction shall be reinforced with the following: Keep surgical mask has been laboratory tested to be washed up to 15 times, when following the care instructions. Stop using the mask if there are visible signs of wear.
Advise on action to be taken by the user and distributor:
Users are advised to take note of the reinforcement of Instructions for Use. Distributors shall add a new sticker or attach notice with the reinforced IFU to existing packaging in storage.
Action taken by manufacturer: 4N Health Oy Ltd will contact distributors and ask them to add stickers or attach notice to existing packaging. 4N Health will recall packaging sent to pharmacies and add new stickers to packaging. Future production will follow the revised labelling.
Potential risks to users: If used incorrectly, the mask may lose its effectiveness as a TYPE II surgical mask. The mask does not pose any direct hazard to users.
Transmission of this Field Safety NoticeThis notice needs to be passed on all those who need to be aware within your organisation or to any organisation where the potentially affected products have been transferred. Please transfer this notice to other organisations on which this action has an impact. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action.
Contact reference person: In case of any questions please contact: Henrik Jæger, Partner, Keep Safe Denmark, hj@e-keepsafe.dk, +45 28 10 81 20 or Magdalena Pawlowicz, Technical manager, Keep Finland. magdalena@4nature.fi, +358 407 403 525 or 
The undersign confirms that this notice has been notified to the following:

  • Fimea (Finland)
  • Laegemiddelstyrelsen (Denmark)

Nyeste test:
BACTERIAL FILTRATION EFFICIENCY (Filtration) _EN14683:2019+AC 2019:
Test conditions: Temperature and Relative humidity: 21±5oC / 85± 5 %
Dimensions of the test specimens: 49cm2 (5 test specimens)
Side of the test specimen facing the challenge aerossol: intern
Air flow rate: 28.3 l/min.
MPS 2.9
Test specimen 1 ,Test specimen 2,Test specimen 3,Test specimen 4,Test specimen 5 (%)
98,2
98,3
99,0
98,8
98,5
Domestic washing and drying :
Type machine: horizontal axis, front-loading Ballast used: 100% cotton
Detergent: Det. Ref. 3
Total dry mass: 2.0 ±0.1 Kg
Drying procedure: Ironing between every wash (1sec.)
15 washing cycles with Ironing between every wash (1sec.)

SPLASH RESISTANCE PRESSURE _ISO 22609:2004:
Test conditions: Samples pre-condictioned for at least 4 hoursat Temperature and Relative humidity: 21±5oC / 85± 5 %

Samples exposed to a jet of 2mL synthetic blood at pressure (low: 10.6 KPa; medium: 16.0 KPa; high: 21.3 KPa) aimed at the centre of the mask.
Test performed at laboratory temperature of 21oC and 45% relative humidity, within 60 seconds after the mask was removed from the conditioning chamber
Observation after 10+1 second of blood penetration on the opposite side of the mask.
Synthetic blood according to Annex B of ISO 22609: 2004 with surface tension of 42 + 2mN / m, batch L202014
Number and General location of the áreas: 32 test specimen / center (pass at least Medium pressure test for 29 out of 32 samples as minimum, corresponding to AQL 4%, acording EN 14683: 2019 mask Type IIR)
32 test specimen
General location of the áreas: center
Pass at least Medium pressure test for 29 out of 32 samples as minimum, corresponding to AQL 4%, acording EN 14683: 2019 mask Type IIR. Results: Low pressure (10.6KPa)  _specimen "pass", _specimen "fail"
Médium pressure (16.0KPa) 32 specimen "pass", 0 specimen "fail"
All 32 samples Pass
Head harness strength :
Verification of resistance to 5 cycles of placement and removal, in 3 test subjects, with different morphologies.
Visual Inspection:
- Nasal clip adjustment - Rips,
- Deformations,
- Wear,
- Facial Coverage