Health product recall

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