Product Advisory Notice

While recently recertifying EVA Respirators under the European Union’s PPE Regulation, Bullard learned that the 20LF Hood, CC20 Hood, and FC4 Filter used with the EVA Respirator system did not consistently comply with all requirements under the European Respiratory Requirements Standard (EN12941:1998 +A2:2008).

CE Marking/EN Certification Customers NIOSH Approval Customers
Customers who purchased this equipment where
CE Marking/EN Certification was required for use (primarily in Europe):
Customers who purchased this equipment where NIOSH approval was required for use (primarily in the Americas, Middle East and Asia Pacific regions):
Please STOP USING those products and contact Bullard, as detailed in this Product Advisory Notice.
NO IMPACT. Customers may continue to use the products.

Bullard strives to always protect our customers. Our commitment is to safety and we are informing you, our customers, of this product advisory notice so you can make the best decision for your business and customers. We stand true to our vision to advance human safety to enable long, healthy, and productive lives. Below are the details of this Product Advisory Notice.

1. LF and LF2 Hoods used with EVA Respirator sold between 2011 and 2020 where CE Marking/EN Certification is required

Products Affected:

  • LF-Series Hoods: 20LFM, 20LFL, 20LFXL 
  • LF2-Series Hoods: 20LF2S, 20LF2M, 20LF2L

NOTICE: Possible reduction of protection level as specified by EN12941:1998 + A2:2008

Summary

  • TH2 and TH3 level protection (EN12941:1998 + A2:2008) cannot be assured for all wearers in all cases.
  • Hoods continue to provide TH1 (EN12941:1998 + A2:2008) level protection.
  • If your application requires protection greater than TH1 (EN12941:1998 + A2:2008), stop using immediately and contact Bullard (see appendix below) for a full refund.
  • If your application requires TH1 (EN12941:1998 + A2:2008) protection, the product is appropriate for continued use.

Details

The LF and LF2 hoods were certified under the European Union’s PPE Directive in 2011 and Total Inward Leakage (“TIL”) testing as prescribed by EN12941:1998 + A2:2008 demonstrated compliance to a TH3 level of protection. While recently recertifying these products under the European Union’s PPE Regulation, TIL testing was again performed and the TH3 protection level could not be consistently verified for all subjects under all test conditions.

Each hood style comes in three (3) sizes. When the hoods were selected by the test subjects, it was determined that it is possible for a user to select an incorrect hood size that may not provide the expected level of protection. The results varied by subject, the size that was selected, the size and shape of the user’s face, and the activities being performed, and, in some cases, the protection changed from a TH3 to a TH1. If the application in which your respirator is being used requires protection level TH2 or TH3, then immediately stop using the respirator and contact Bullard (see appendix below) for a full refund. Users in applications requiring TH1 level protection can continue to safely use the respirator.

2. CC20 Hoods used with the EVA Respirator sold between 2011 and 2020 where CE Marking/EN Certification is required

Products Affected:

  • CC20-Series Hoods: 20TJN, 20TJ, 20TJNT, 20TJT, 20TICN, 20TIC, 20TICNT, 20TICT, 20TICSN, 20TICS, 20TICSNT, 20TICST, 20SICN, 20SIC, 20SICNT, 20SICT, 20TICH, 20TICHC30R, 20TICHT, 20TICHTC30R, 20SICH, 20SICHT

NOTICE: Possible Carbon Dioxide (CO2) content of exhalation air exceeding 1% as specified by  EN12941:1998 + A2:2008

Summary

  • CO2 content of exhalation air could exceed 1% (as per EN12941:1998 + A2:2008). Values as high as 1.7% have been measured in recent testing.
  • As a result, in countries where CE Marking/EN Certification is required, immediately stop using the product and contact Bullard (see appendix below) for a full refund. NIOSH does not regulate the CO2 content of exhalation air for these products; however, in light of these recent findings, if you have concerns, please contact Bullard for additional information.

NOTICE: Possible noise level exceeding 75dBA as specified by EN12941:1998 + A2:2008

Summary

  • Noise level could exceed 75dBA (as per EN12941:1998 + A2:2008) by as much as 3dB.
  • As a result, in countries where CE Marking/EN Certification is required, immediately stop using the product and contact Bullard (see appendix below) for a full refund.

Details

The CC20 Hoods were certified under the European Union’s PPE Directive in 2011 and testing as prescribed by EN12941:1998 + A2:2008 demonstrated compliance to the noise level and CO2 of exhalation air requirements. While recently recertifying these products under the PPE Regulation, noise level and CO2 of exhalation air tests were again performed, and these requirements were not consistently met. As a result, in countries where CE Marking/EN Certification is required, immediately stop using the product and contact Bullard (see appendix below) for a full refund.

3. FC4 Combination Filter used with the EVA Respirator sold between 2011 and 2020

Product Affected:

  • Combination Filter: PAPRFC4

NOTICE: Possible Dislodged Carbon

Summary

  • Carbon in the filter may become dislodged during excessive vibration.
  • Use of the product in this condition could cause a reduction in filter performance and the user could see black carbon dust particles within the respirator.
  • If black dust is visible in the filter packaging or on the outside of the filter, do not use the product and contact Bullard (see appendix below) for a full refund.

Details

The FC4 Combination Filter was certified under European Union’s Directive in 2011 and testing prescribed by EN12941:1998 + A2:2008 demonstrated compliance to the Filter Mechanical Strength requirements. While recently recertifying these products under the PPE Regulation, Filter Mechanical Strength tests were again performed, and these requirements were not consistently met. As a result, if black dust is visible in the filter packaging or on the outside of the filter, do not use the product and contact Bullard (see appendix below) for a full refund.

Appendix   

CE Marking/EN Certification Customers
Regions Contact Information
Asia Pacific & Middle East +65-6745-0556 bullardasia@bullard.com
Europe +49-(0)2642-99998-0 info@bullard.de
Americas 1-800-227-0423, Option #3 technicalsupport@bullard.com