Health product recall

Respironics Masks

Brand(s)
Last updated

Summary

Product
Respironics Masks
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected products Lot or serial number Model or catalog number
Wisp Youth Mask, Fabric Frame, W/Hdgr, Dom All lots. 1109298
Amara View Mask W/Hgr All lots. 1090603 1090602 1090604
Dreamwear Full, Med Frm W/ Hgr, Gbl All lots. 1133383 1133380 1133381 1133382
Therapy Mask 3100 Nc, Fitpack, W/Hgr All lots. 1144608
Fitpack, Dreamwisp Nsl, Med Con All lots. 1137918 1137916
Therapy Mask 3100 Sp, Fitpack, W/Hgr All lots. 1144610
Dreamwear Full, Sm & Med Frm, Gbl All lots. 1133375 1133378 1133377 1133376
Wisp Mask, Clear Frame, W/ Hdgr, Intl All lots. 1094060
Dreamwear Full, Sm Frm W/ Hgr, Gbl All lots. 1133386 1133387 1133385 1133388
Dreamwear Full, Med Frm W/O Hgr, Gbl All lots. 1133407 1133405 1133406
Wisp Mask, Clear Frame, W/ Hdgr, Dom All lots. 1094050
Wisp Mask, Fabric Frame, W/ Hdgr, Dom All lots. 1094051
Dreamwisp Nsl, Med Con All lots. 1137923 1137935 1137936 1137926 1137933 1137932 1137922 1137934 1137924 1137925
Fitpack, Dreamwear Full, Med Frame, Gbl All lots. 1133400
Dreamwear Full, Sm Frm W/O Hgr, Gbl All lots. 1133410 1133412 1133411
Dreamwear Full, Lg Frm W/O Hgr, Gbl All lots. 1133416 1133418 1133417
Dreamwear Full, Lg Frm W/ Hgr, Gbl All lots. 1133391 1133392 1133393 1133390
Amara View Mask W/Hgr, Fitpack All lots. 1090670

Issue

The affected masks contain magnets which can potentially affect the functioning and/or induce the movement/dislocation of medical implants or medical devices that can be impacted by the magnetic fields.

Recall start date: September 15, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Respironics Inc.

1001 Murry Ridge Lane, Murrysville, Pennsylvania, United States, 15668

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-64545