RUSCH POLARIS FO SU HANDLE (2021-02-18)
- Starting date:
- February 18, 2021
- Posting date:
- March 4, 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-75071
Last updated:
2021-03-04
Affected Products
- RUSCH POLARIS FO SU PENLIGHT HANDLE
- RUSCH POLARIS FO SU MEDIUM HANDLE
- RUSCH POLARIS FO SU STUBBY HANDLE
Reason
Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge. If the defect is present and is not recognized prior to use, adverse health consequences may result from the use of the device during intubation including delay in intubation and potential injury due to product fragmentation.
Affected products
A. RUSCH POLARIS FO SU PENLIGHT HANDLE
Lot or serial number
- Lot # 19A
- Lot # 19F
- Lot # 19J
Model or catalog number
44401
Companies
- Manufacturer
-
Teleflex Medical
3015 Carrington Mill Blvd
Morrisville, North Carolina
27560
North Carolina
UNITED STATES
B. RUSCH POLARIS FO SU MEDIUM HANDLE
Lot or serial number
- Lot # 19F
- Lot # 19J
- Lot # 19P
- Lot # 19W
- Lot # 205
Model or catalog number
44402
Companies
- Manufacturer
-
Teleflex Medical
3015 Carrington Mill Blvd
Morrisville, North Carolina
27560
North Carolina
UNITED STATES
C. RUSCH POLARIS FO SU STUBBY HANDLE
Lot or serial number
- Lot # 19A
- Lot # 19F
Model or catalog number
44403
Companies
- Manufacturer
-
Teleflex Medical
3015 Carrington Mill Blvd
Morrisville, North Carolina
27560
North Carolina
UNITED STATES