adult oxygen mask high concentration (2020-06-18)
- Starting date:
- June 18, 2020
- Posting date:
- April 1, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-75271
Last updated:
2021-04-01
Affected Products
adult oxygen mask high concentration
Reason
CHS LTD. is submitting a recall on behalf of SUNMED HOLDINGS on Prod. Code 2101F, Lot #191000537 and lot #190900425 due to the incorrect product in the package. Both the case and pouch labels are labeled as product code # 2101F, Lot #191000537 or Lot #190900425; however, the actual product inside the pouch is product code #2102F which has a slightly different function than P/N 2101F.
Affected products
adult oxygen mask high concentration
Lot or serial number
- 190900425
- 191000537
Model or catalog number
- 2101F
Companies
- Manufacturer
-
SUNMED HOLDINGS, LLC DBA VENTLAB, LLC
2710 NORTHRIDGE DRIVE NW, SUITE A
GRAND RAPIDS
49544
Michigan
UNITED STATES