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Shiley Tracheostomy Tube (2015-05-11)
- Starting date:
- May 11, 2015
- Posting date:
- June 3, 2015
- 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-53663
Recalled Products
- Shiley Neonatal Tracheostomy Tube
- Shiley Pediatic Tracheostomy Tube
- Shiley Long Pediatic Tracheostomy Tube
- Shiley Neonatal Tracheostomy Tube Cuffless
- Shiley Pediatic Tracheostomy Tube Cuffless
- Shiley Pediatic Long Tracheostomy Tube
Reason
Recall initiated following reports from customers where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort immediately after the switch in a limited number of situations. In some cases, breathing difficulties, corresponding to a negative effect on oxygen levels, were also observed immediately after the switch.
Affected products
A. Shiley Neonatal Tracheostomy Tube
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 2.5NCF
- 3.0NCF
- 3.5NCF
- 4.0NCF
- 4.5NCF
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
Massachusetts
UNITED STATES
B. Shiley Pediatic Tracheostomy Tube
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 2.5PCF
- 3.0PCF
- 3.5PCF
- 4.0PCF
- 4.5PCF
- 5.0PCF
- 5.5PCF
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
Massachusetts
UNITED STATES
C. Shiley Long Pediatic Tracheostomy Tube
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 5.0PLCF
- 5.5PLCF
- 6.0PLCF
- 6.5PLCF
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
Massachusetts
UNITED STATES
D. Shiley Neonatal Tracheostomy Tube Cuffless
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 2.5NEF
- 3.0NEF
- 3.5NEF
- 4.0NEF
- 4.5NEF
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
Massachusetts
UNITED STATES
E. Shiley Pediatic Tracheostomy Tube Cuffless
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 2.5PEF
- 3.0PEF
- 3.5PEF
- 4.0PEF
- 4.5PEF
- 5.0PEF
- 5.5PEF
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
Massachusetts
UNITED STATES
F. Shiley Pediatic Long Tracheostomy Tube
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 5.0PELF
- 5.5PELF
- 6.0PELF
- 6.5PELF
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
Massachusetts
UNITED STATES