Device product
HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used to aspirate liquids or semisolids from a patient's upper airway.
Z-2369-2015
Product summary
- Firm
- Teleflex Medical
- Event
- Event 71360
- Status
- Terminated
- Classification
- Class I
- Quantity
- 188,195 total units
- Official record key
device-enforcement:Z-2369-2015
Official wording
Reason: The double swivel connector may crack or separate on the endobronchial tube.
Code information: Product Code: 5-16142, Lot numbers: 01J1300535, 01M1300215, 01A1400321, 73D1400579 and 73E1400113.
Distribution pattern: Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.
Derived failure modes
-
Unknown
The double swivel connector may crack or separate on the endobronchial tube.