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: 2022-09-16
Alert / recall type
Health product recall
Category
Health product - Medical device - 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