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
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